i

OUTCOME OF DELAYED CORD CLAMPING IN TERM NEONATES

AT THE FEDERAL MEDICAL CENTRE, ABEOKUTA: A RANDOMIZED

CONTROLLED STUDY

A DISSERTATION SUBMITTED BY:

DR. AWOLAJA, BABATUNDE STEPHEN M.B;B.S (Ibadan)

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY

FEDERAL MEDICAL CENTRE, ABEOKUTA.

TO:

THE NATIONAL POSTGRADUATE MEDICAL COLLEGE

OF NIGERIA.

FOR THE PART TWO FELLOWSHIP EXAMINATION IN

THE FACULTY OF OBSTETRICS AND GYNAECOLOGY

NOVEMBER 2016

ii

DEDICATION

Gabriel Koleade and Deborah Olufunmilayo Awolaja, my late parents.

iii

SUPERVISOR’S ENDORSEMENT

I hereby declare that this dissertation: Outcome of delayed cord clamping in term neonates at

the Federal Medical Centre, Abeokuta was conceptualized and developed after a problem

identification and discussion with me by Dr Awolaja Babatunde Stephen.

I also supervised the conduct of the study, analysis of the data and write-up of this final report.

I am certain that the candidate undertook the study conscientiously.

.........................................................................................

DR. D.O. AWONUGA

M.B.B.S., FMCOG, FWACS, MSc (Rep. Biology)

Consultant Obstetrician/Gynaecologist

Department of Obstetrics & Gynaecology

Federal Medical Centre, Abeokuta

iv

SUPERVISOR’S ENDORSEMENT

I hereby declare that this dissertation: Outcome of delayed cord clamping in term neonates at

the Federal Medical Centre, Abeokuta was conceptualized and developed after a problem

identification and discussion with me by Dr Awolaja Babatunde Stephen.

I also supervised the conduct of the study, analysis of the data and write-up of this final report.

I am certain that the candidate undertook the study conscientiously.

........................................................................................

DR. A.S. ADEBAYO

M.B.B.S., FWACS

Consultant Obstetrician/Gynaecologist

Department of Obstetrics & Gynaecology

Federal Medical Centre, Abeokuta.

v

SUPERVISOR’S ENDORSEMENT

I hereby declare that this dissertation: Outcome of delayed cord clamping in term neonates at

the Federal Medical Centre, Abeokuta was conceptualized and developed after a problem

identification and discussion with me by Dr Awolaja Babatunde Stephen.

I also supervised the conduct of the study, analysis of the data and write-up of this final report.

I am certain that the candidate undertook the study conscientiously.

........................................................................................

DR. I.O.F. DEDEKE

M.B.chB., FWACPaed

Consultant Neonatologist

Department of Paediatrics

Federal Medical Centre, Abeokuta.

vi

DECLARATION

I hereby declare that this work, outcome of delayed cord clamping in term neonates at the

Federal Medical Centre, Abeokuta is genuine unless otherwise acknowledged.

..................................................................................

Dr. Awolaja Babatunde Stephen (MBBS, Ibadan)

vii

ACKNOWLEDGEMENT

My profound gratitude goes to God Almighty for his sustenance, my preceptor Dr A.S

Adebayo for looking through the initial draft and all the other consultants, Dr A.O Oladimeji,

Dr M.O Alao, Dr K.I Hunyinbo and Dr T.A Ogunfunmilayo for their contribution and

guidance.

My profound gratitude also goes to my Head of Department Dr D.O Awonuga for his review

and comments, to Dr I.O.F Dedeke Head of Paediatrics Department for her review,

comments, contribution to the statistical analysis and for constantly urging me on and for

practically keeping me on my toes during the final write up.

I would like to thank all my colleagues for their advice and constructive criticism, my junior

colleagues, midwives and all the members of the nursing department who helped out during

the study and to the paediatric residents who helped with sample collection and clinical

assessment of the babies.

Special thanks go to Dr Olawale and Miss Damilola who helped with the laboratory analysis

of the blood samples.

To my wife, Adenike and children Oluwasemiloore and Oluwafikemi, I am deeply grateful.

Lastly, I would like to thank, and very specially, the women and children who participated in

the study. For without them, the study would not have been possible.

viii

TABLE OF CONTENT

TITLE i

DEDICATION ii

ENDORSEMENT iii

DECLARATION vi

ACKNOWLEDGEMENT vii

CONTENT viii

ABBREVIATIONS x

LIST OF TABLES xi

ABSTRACT xii

CHAPTER ONE

INTRODUCTION 1

CHAPTER TWO

LITERATURE REVIEW 3

JUSTIFICATION 14

CHAPTER THREE

OBJECTIVE 15

CHAPTER FOUR

METHODOLOGY 16

ETHICAL CONSIDERATION 21

CHAPTER FIVE

RESULTS 23

TABLES 26

HYPOTHESIS TESTING 30

ix

CHAPTER SIX

DISCUSSION 31

LIMITATIONS OF THE STUDY 35

CONCLUSION 36

RECOMMENDATIONS 37

AREAS OF FURTHER RESEARCH 37

REFERENCES 38

APPENDICES 43

x

ABBREVIATIONS

eds editors

e.g. for example

et al and others

g gram

s second

μg microgram

BSc Bachelor of Science

CI confidence interval

DCC delayed cord clamping

dL decilitre

ECC early cord clamping

EDTA ethylenediamine tetraacetate

EMCS emergency caesarean section

FMC Federal Medical Centre

Fl femtolitre

FMCOG Fellow of the Medical College of Obstetrics

and Gynaecology

FWACS Fellow of the West African College of Surgeons

HND Higher National Diploma

HREC Health Research Ethics Committee

IDA iron deficiency anaemia

Kg kilogram

LMP last menstrual period

MBBS Bachelor of Medicine;Bachelor of Surgery

mg milligram

NCE National Certificate of Education

ND National Diploma

NTD neural tube defect

PCV packed cell volume

PPH postpartum haemorrhage

SD standard deviation

SPSS statistical package for social sciences

USS ultrasound scan

WHO world health organization

xi

LIST OF TABLES PAGE

Table I. Maternal characteristics 26

Table II. Newborn characteristics 26

Table III. Neonatal haematological outcome at 24 hours of life 27

Table IV. Neonatal secondary outcome 28

Table V. Haematocrit at 6 weeks of life 29

xii

ABSTRACT

Background: Early cord clamping has been postulated as a major cause of anaemia in

infancy and there is no sound evidence to support this approach which might deprive the

newborn of some benefits such as an increase in iron storage. Iron deficiency anaemia is a

serious health problem that affects the physical and cognitive development of children.

Therefore, it is important to develop cost-effective interventions aimed at improving the

haematologic status of the millions of children affected by this condition worldwide. Delayed

clamping of the umbilical cord increases newborn iron endowment and is not associated with

adverse effects.

Objective: To determine the haematological and clinical effects of delayed umbilical cord

clamping in term neonates.

Methodology: This was a prospective randomized controlled study which was carried out at

the labour ward of the department of Obstetrics and Gynaecology, Federal Medical Centre,

Abeokuta. A total of 110 mother-infant pairs who met the inclusion criteria were assessed

and randomized into two groups; early cord clamping group (within 10s) and delayed cord

clamping group (at 2 minutes) and followed up until 6 weeks postpartum.

Results: Ninety-nine mother-infant pairs completed the study. At 24 hours of life, the mean

venous haematocrit was significantly higher in babies that had delayed cord clamping (t =

10.51, df = 97, p = 0.0001), an effect that persisted until 6 weeks postpartum. The delayed

cord clamping group also had a significantly lower prevalence of anaemia at 24 hours. (p =

0.0001).

Although the mean serum bilirubin was significantly higher in the delayed cord clamping

group, there were no significant differences in respiratory symptoms, admission into NICU,

need for phototherapy and newborn length of hospital stay between the two groups.

Conclusion: Delayed cord clamping compared with early cord clamping resulted in

improved neonatal haematocrit value and reduced prevalence of anaemia at 24 hours of life,

without increasing the risk of neonatal morbidity.

Recommendation: The practice is safe and should be incorporated into delivery protocols in

our environment to reduce the incidence of neonatal anaemia.

1

CHAPTER ONE

1.0 INTRODUCTION

The optimal timing of umbilical cord clamping has been and still remains a highly

controversial issue.1-4 Clamping and cutting of the umbilical cord at birth is by far the oldest

and most prevalent interventions in humans. In spite of this, the ideal timing for cord

clamping has yet to be established and there are no clear-cut guidelines on the clamping of

umbilical cord after child birth.

Before the mid 1950s, the term “early clamping” was defined as umbilical cord

clamping within 1 minute of birth, and “late clamping” was usually reserved for clamping

done more than 5 minutes after birth. Investigators in Sweden, the United States and Canada,

in a series of studies of blood volume changes after birth reported that in healthy term babies,

more than 90% of blood volume was achieved within the first few breaths the baby took after

birth.5 Due to the results of these findings and the lack of specific recommendation regarding

the optimal timing, the interval between birth and umbilical cord clamping began to be

shortened.

Also, management of the third stage of labour has typically focused on women and

prevention of postpartum haemorrhage. A systematic review published in 2000 found that

active management of third stage of labour which involved the use of oxytocics, early cord

clamping, and controlled cord traction was superior to expectant management in terms of

maternal blood loss.6 For this reason, early clamping was accepted into obstetric practice

without much consideration.

However, there is growing evidence that our haste to clamp the umbilical cord and

pass the baby off is ill advised. It has been argued that early cord clamping puts the newborn

at increased risk of hypovolaemic damage and iron loss, as well as several blood disorders

and type 2 diabetes, as a consequence of loss of haemopoietic stem cells.7,8

Furthermore, early cord clamping has been postulated as a major cause of anaemia in

infancy, and this has led some investigators to recommend late clamping as a low-cost

intervention to reduce anaemia during the first 6 months of life.

One of the most critical factors contributing to neonatal and infant mortality in

developing countries is anaemia,9 which has been repeatedly shown to be an intractable

problem even with antimalarial and iron interventions.

In developing countries, up to 50% of children become anaemic by 12 months of

age.10 Iron deficiency anaemia (IDA) during infancy and childhood is of particular concern

2

because of potentially detrimental effects on development, some of which might be

irreversible even after iron treatment.11 Iron stores at birth are a major factor influencing

growth and the occurrence of IDA during infancy12 and available evidence suggests that it is

important to prevent iron deficiency in infants in order to achieve optimal brain development.

However, the types of interventions that can be implemented during this time are

either not cost effective or difficult to implement, especially in developing countries.

A first step towards reducing anaemia in infancy can be taken during birth. Delayed

cord clamping could be a cost-effective intervention to improve the iron status of babies at

birth.

Studies have shown that delayed cord clamping could contribute to preventing iron

deficiency anaemia in the first year of life.13,14 A recent systematic review confirms the

benefit of delayed cord clamping.15

The reason for this effect is based on the fact that after birth, the newborn is delivered

with a placental transfusion of approximately 80 ml of blood at 1 minute after birth and 100

ml at 3 minutes after birth.7,16 This volume will supply 40-50 mg/kg of extra iron to the

approximately 75 mg/kg of body iron that term newborn babies have, reaching a total of 115-

120 mg/kg which might prevent iron deficiency in the first year of life.4,14

Conversely, some observational studies suggest that delayed umbilical cord clamping

put newborns at higher risk of suffering from polycythaemia, respiratory symptoms,

hyperbilirubinaemia, and other neonatal disorders.17-19 However, there have been no

randomized controlled trials showing the risk of these harmful effects on the newborn.

Many tertiary institutions in Nigeria still practice early cord clamping, despite weight

of current evidence demonstrating the benefits of delayed cord clamping after birth, and there

is no published local data on the subject matter.

The aim of this study was to evaluate the haematological and clinical effects of

delayed cord clamping in term neonates at the Federal Medical Centre, Abeokuta.

3

CHAPTER TWO

2.0 LITERATURE REVIEW

The optimal timing of cord clamping has been a controversial issue for decades, and

there is little agreement among doctors and midwives about the optimal time to clamp the

umbilical cord after birth.20

The most important point of difference relate to maternal and infant safety. Many

healthcare workers worldwide tend to clamp the cord and pass the baby off as quickly as

possible. Infants in resource poor settings are the main victims of immediate clamping, as this

prevents a cost-free means of boosting their small iron stores.20

Delayed clamping of the umbilical cord is a physiological and inexpensive means of

enhancing haematologic status, preventing anaemia, enriching iron stores and ferritin levels

of infants and it is of particular importance for developing countries in which anaemia during

infancy and childhood is highly prevalent.10

2.1 THE FETAL-PLACENTAL CIRCULATION

During pregnancy, the fetal-placental circulation transports oxygen and nutritional

elements from the placenta to the fetus, and metabolic residues from the fetus to the placenta.

The total fetal blood volume is approximately 115 ml/kg. The proportion of fetal blood that at

any moment circulates in the placenta diminishes during pregnancy, and is estimated to be

around 50% at 30 weeks of gestation and 35% at term.21

For a normal term pregnancy, with a fetus weighing 3.5kg, this distribution

corresponds to approximately 140ml of blood in the placenta and 260 ml in the fetus.

After delivery, blood circulates in the umbilical arteries from the newborn baby

mainly during the first 25 seconds and after 45 seconds, the circulation becomes negligible

indicating a closure of the fetal-placental circulation. In contrast, the blood flow from the

placental side to the baby through the umbilical vein is maintained during the first 3 minutes

of birth, largely influenced by uterine contractions.22 Consequently, a net transfusion of blood

from the placenta to the baby is accomplished.

The total placental transfusion to the baby is about 30 ml/kg, leaving 15 ml/kg in the

placenta. The placental transfusion occurs mainly within 1 minute, and is usually complete

after 3 minutes.23 Also, the level of the baby in relation to the placenta affects the placental

transfusion.

4

If the baby is held 20 cm below the placenta, the complete transfusion will be

performed within 1 minute, but if the baby is held 20 cm above the level of the placenta, the

transfusion will be about 20 ml/kg, and at 40 cm above the placenta, no transfusion occurs.

The rate of transfusion is also dependent on uterine contractions.24

2.2 UMBILICAL CORD CLAMPING AFTER BIRTH

In 1801, Erasmus Darwin wrote “Another thing very injurious to the child is the tying

and cutting of the navel string too soon, which should always be left till the child has not only

repeatedly breathed but till all pulsation in the cord ceases. As otherwise the child is much

weaker than it ought to be, a part of the blood being left in the placenta which ought to have

been in the child.”25

Most mammals in the animal kingdom wait until the expulsion of the placenta to

sever the umbilical cord from their newborn after delivery. In humans, the attendant aiding

the delivery clamps and severs the umbilical cord much before the placenta is delivered; often

within a few seconds of the baby’s birth.

The practice of early cord clamping started in the 20th century with increasing number

of women opting for hospital births and increasing number of obstetricians conducting such

deliveries.26

Early clamping and cutting of the umbilical cord is widely practised as part of the

management of labour but recent studies suggest that it may be harmful to the baby.27

Early clamping of the cord was one of the first routine medical interventions in

labour. Its place in modern births was guaranteed by its incorporation into the triad of

interventions that make up the active management of the third stage of labour. The earliest

references are clear about the other two components of active management – oxytocin to

contract the uterus and prevent postpartum haemorrhage, and controlled cord traction to

prevent retention of the placenta.28

But early cord clamping had no specific rationale, and it probably entered the protocol

by default because it was already part of standard practice. When this package was shown to

reduce postpartum haemorrhage in the 1980s, early cord clamping became enshrined in the

modern management of labour.27

5

2.3 ACTIVE MANAGEMENT OF THE THIRD STAGE OF LABOUR

The third stage of labour is that period of time from birth of the baby until delivery of

the placenta.6

There are two contrasting approaches to managing the third stage of labour: active

management and expectant or physiological management.

Expectant management is a non-interventionist approach which involves waiting for

signs of placental separation and allowing the placenta to deliver spontaneously or aided by

gravity, maternal effort or nipple stimulation. Active management usually involves the

clinician intervening in the process through three interrelated processes; the administration of

a prophylactic uterotonic drug; early cord clamping and cutting; and controlled traction of the

umbilical cord.29

A major reason for practising active management is its association with reduced risk

of postpartum haemorrhage (PPH), the major complication of the third stage of labour.6

PPH is the most common fatal complication of pregnancy and childbirth in the world30,31 and

is a major contributor to the conservatively estimated 500,000 maternal deaths occurring

throughout the world annually.30,32 Whilst the majority of maternal deaths (99%) occur in

low-income countries33, the risk of PPH should not be underestimated for any birth.34

Although active management leads to reduced risk of PPH, it is important to establish which

component of the strategy lead to this reduced risk.

Trials show that early cord clamping has no effect on the risk of retained placenta or

postpartum haemorrhage.35,36

Evidence from a Cochrane review supports this result – prophylactic oxytocin reduces

the risk of postpartum haemorrhage whether the rest of the active management package is

adopted or not.37 Another systematic review published in 2008 studied the effects of different

cord clamping times on maternal blood loss and found that delayed clamping poses no

additional threats to women.29

2.3.1 DEFINITION OF EARLY AND DELAYED CORD CLAMPING

Different definitions of early cord clamping (ECC) have been used, with the time

varying from immediately to within one minute after delivery of the baby. In modern trials,

ECC has usually been defined as clamping within 10 – 30 seconds after birth.

Delayed cord clamping is usually defined as cord clamping within 2 – 3 minutes after

delivery or after cessation of cord pulsations.29,38

6

2.3.2 EFFECTS OF EARLY AND DELAYED CORD CLAMPING IN TERM

NEONATES

Advocates for early cord clamping argue that delayed cord clamping can be

physiologically distressing on the baby’s circulation and that the risk of polycythaemia and

jaundice is increased. Other rationales for ECC are the recommendation to practice ‘active

management of the third stage of labour,’ in which ECC has been a part, and the routine

assessment of the acid-base status of umbilical cord blood at birth. More recently, the new

possibility of harvesting haematopoietic stem cells from the placental-fetal blood has been

associated with a need for ECC. Since an increased volume of blood can be collected from

the placental circulation after early cord clamping, a higher count of stem cells can be

harvested.

In the past, paediatricians recommended early cord clamping because of fears that

over-transfusion caused polycythaemia, hyperviscosity syndrome or hyperbilirubinaemia.

However, a recent high quality meta-analysis of randomized controlled trials from the past 15

years convincingly showed that delayed cord clamping in full term neonates for a minimum

of two minutes is beneficial to the newborn, and that this benefit extends into infancy.39

The benefits include, improved haematological status measured as haematocrit value,

ferritin concentration, and stored iron, and a clinically important reduction in the risk of

anaemia. An increase was seen in polycythaemia, but it seemed to be benign. No significant

differences were seen between delayed and early cord clamping in the risk of neonatal

jaundice.

Although paediatricians think that early cord clamping is needed in babies who

require immediate neonatal resuscitation, these cases are exceptions. Most newborn babies do

not require resuscitation, immediate drying and keeping them warm is all that is needed. Less

than 10% of newborns need help to start breathing at birth (stimulation, positioning, clearing

the airway), and about 1% need extensive resuscitation.40 When respiratory efforts are absent

or inadequate despite initial stabilization, inflation breaths by mask ventilation are the

priority.40 The earliest time to assess whether these inflation breaths are successful is about

60 seconds after delivery. All these steps can be done while the umbilical cord is intact.41

Immediate clamping to enable resuscitation away from the mother could deprive the

baby of the much needed extra blood volume, and the resulting hypovolemia might adversely

affect tissue perfusion. Furthermore, as long as the uterus is not contracting and the placenta

has not been detached, the baby may still receive oxygen via the intact placental-fetal

circulation.

7

2.3.3 IRON DEFICIENCY ANAEMIA

Iron deficiency is the most common cause of anaemia in every country of the world.

Iron is one of the most common elements in the Earth’s crust, yet iron deficiency is the most

common cause of anaemia, affecting about 500 million people worldwide.42 This is because

the body has a limited ability to absorb iron and excess loss of iron as a result of haemorrhage

is frequent. Also, in many developing countries, dietary intake is inadequate from childhood.

Iron deficiency and iron deficiency anaemia are major public health problems in

young children worldwide, and are associated with poor neurodevelopment.

Young children are at particular risk of iron deficiency because of high iron

requirements during rapid growth in combination with low iron intake. Globally, about a

quarter of preschool children have iron deficiency anaemia, the most severe form of iron

deficiency.43

Its prevalence is highest among under five children in developing countries where

approximately 50% are affected.10

Iron is essential for several aspects of brain development, including myelination,

dendritogenesis, neurotransmitter function, and neuronal and glial energy metabolism.43,44

Iron deficiency anaemia in young children is associated with long lasting cognitive and

behavioural deficits.45 Iron deficiency without established anaemia has also been associated

with altered affective responding, impaired motor development, and cognitive delays.11,46-48

Two recent meta-analysis have concluded that iron supplementation improves psychomotor

and mental development in infants and children.49,50

Consequently, since delayed cord clamping (DCC) is associated with improved iron

status in infants, it could also have an impact on iron deficiency related adverse effects.

2.4 COMPARATIVE STUDIES ON EARLY VS DELAYED CORD CLAMPING

Physiological and health effects of cord clamping in relation to time after delivery

have been studied since 1875.51 Yet the controversies surrounding the optimal timing of cord

clamping remain unresolved.

Grajeda13 et al., 1997 conducted a randomized clinical trial in a low-income

Guatemalan population in which the effect of delayed clamping of the umbilical cord on

infant iron status was examined.

They randomly assigned 69 Guatemalan newborns into one of three groups at the time

of delivery: 1, cord clamping immediately after delivery (n = 21): 2, clamping when the cord

8

stopped pulsating, with the baby placed at the level of the placenta (n = 26): or 3, clamping

when the cord stopped pulsating, with the newborn placed below the level of the placenta

(n = 22). Maternal and infant haematologic assessments were performed at the time of

delivery and 2 months postpartum. At baseline, the newborns had similar haematocrit status

and the clinical assessment (including jaundice) revealed no significant difference in newborn

health status across groups. However, polycythaemia (percentage with a haematocrit value >

0.65) was more likely to occur in the group with delayed clamping and placement of the

newborn below the placenta (2 of 22) than in the other two groups (0 of 22). Both subjects

with polycythaemia were asymptomatic and their haematocrit values were just above the cut-

off value (0.656 and 0.660).Two months after delivery, infants in the two groups with

delayed cord clamping had significantly higher haematocrit values and haemoglobin

concentrations than did those in the early clamping group. The percentage with haematocrit

values < 0.33 was 88% in the control group compared with 42% in group 2 and 55% in group

3 (p = 0.01). Maternal haematologic indexes were similar among groups both at baseline and

2 months after delivery. Their result suggested that waiting until the umbilical cord stopped

pulsating (~ 1 minute after delivery) is a feasible low-cost intervention that can reduce

anaemia in infants in developing countries.

A limitation of this study was that all the deliveries were attended by the first author

who also performed all anthropometric measurements on the infants hence the possibility of

selection and ascertainment biases cannot be excluded.

Gupta and Ramji52, 2002 in a randomized controlled trial to study the effects of cord

clamping on iron stores of infants born to anaemic mothers at 3 months of age, randomized

102 neonates into early (n = 43) or delayed cord clamping (n = 59). The women assigned to

the early cord-clamping group had their cords clamped immediately after the birth of the

baby while those assigned to delayed cord-clamping group had their cords clamped after the

placenta had descended into the vagina. The mean infant ferritin and haemoglobin at 3

months were significantly higher in the delayed clamping group (118.4 μg/L and 99 g/L) than

in the early clamping group (73 μg/L and 88 g/L). The mean decrease in haemoglobin (g/L)

at 3 months adjusted for co-variates was significantly less in the delayed clamping group

compared to the early clamping group (-1.09, 95% CI -1.58 to -0.62, p <0.001). The odds for

anaemia (<100 g/L) at 3 months was 7.7 (95% CI 1.84 – 34.9) times higher in the early

compared to the delayed clamping group. They therefore concluded that iron stores and

haemoglobin in infancy can be improved in neonates born to anaemic mothers by delaying

cord clamping at birth.

9

Van Rheenen53 et al., 2007 conducted a randomized controlled trial to assess whether

delaying umbilical cord clamping was effective in improving the haematological status of

term infants living in a malaria-endemic area, and whether this was associated with

complications in infants and mothers.

They randomly assigned 105 women delivering at term in Mpongwe Mission Hospital

Zambia, to delayed cord clamping (DCC, n = 55) or immediate cord clamping (controls, n =

50) groups. Nine cases in the DCC group and four cases in the control group were excluded

from the analyses. Ninety-one mother-infant pairs were actively followed- up on a bi-

monthly basis until the infants reached the age of 6 months. The haemoglobin (Hb) change

from cord values and the proportion of anaemic infants was compared, and secondary

outcomes related to infant and maternal safety.

Throughout the observation period infant Hb levels in both groups declined, but more

rapidly in controls than in the DCC group [difference in Hb change from baseline at 4 months

1.1 g/dl, 95% CI 0.2;2.1]. By 6 months, this difference had disappeared (0.0 g/dl, 95% CI -

0.9;0.8). The odds ratio for iron deficiency anaemia in the DCC group at 4 months was 0.3

(95% CI 0.1;1.0), but no differences were found between the groups at 6 months. No adverse

events were seen in infants and mothers.

Their findings indicated that DCC could help improve the haematological status of

term infants living in a malaria-endemic region at 4 months of age. However, the beneficial

haematological effect disappeared by 6 months.

The strengths of this study are its randomized design, the low drop-out rate for a rural

area, and the control for confounding factors which could influence infant haematological

status. A limitation is that mothers who were already assigned to a treatment group could

later become ineligible which could not be avoided in view of the timing and nature of the

intervention. Also, the investigators, assessors and mothers were not blinded to the assigned

intervention. This could have biased the clinical evaluation for hyperviscosity syndrome and

hyperbilirubinaemia.

Chaparro54 et al., 2006 in another randomized controlled trial to assess whether a 2-

minute delay in the clamping of the umbilical cord of normal-weight, full-term infants

improved iron and haematological status up to 6 months of age. In their study,476 mother-

infant pairs were recruited at a large Obstetrics hospital in Mexico City, randomly assigned to

delayed clamping (2 minutes after delivery of the baby’s shoulders) or early clamping

(around 10 seconds after delivery), and followed up until 6 months postpartum.

10

Three hundred and fifty eight (75%) mother-infant pairs completed the trial. At 6 months of

age, infants who had delayed clamping had significantly higher mean corpuscular volume

(81.0 fL vs 79.5 fL 95% CI -2.5 to -0.6, p = 0.001), ferritin (50.7 μg/L vs 34.4 μg/L 95% CI -

30.7 to -1.9, p = 0.0002), and total body iron. The effect of delayed cord clamping was

significantly greater for infants born to mothers with low ferritin at delivery, breastfed infants

not receiving iron-fortified milk or formula, and infants born with birth weight between

2500g and 3000g. A cord clamping delay of 2 minutes increased 6-month iron stores by

about 27-47 mg. They recorded no significant increase in the risk of neonatal polycythaemia

and jaundice.

They concluded that a delay in cord clamping of 2 minutes could help prevent iron

deficiency from developing before 6 months of age, when iron-fortified complementary foods

could be introduced.

The findings by Chaparro et al agrees with the findings of Grajeda et al and findings

by Gupta and Ramji which showed improved haematological and iron status at 2-3 months.

However, in contrast with the study by van Rheenen, this effect lasted beyond 3 months.

Andersson O55 et al., 2011 in a bid to investigate the effects of delayed umbilical cord

clamping on neonatal outcomes and iron status at 4 months of age in a European setting

conducted a randomized controlled trial in a Swedish county hospital in which 400 full term

babies born after a low risk pregnancy were randomized to delayed umbilical cord clamping

(≥180seconds after delivery) or early clamping (≤10 seconds after delivery). The main

outcome measures were haemoglobin and iron status at 4 months of age with the power

estimate based on serum ferritin levels. Secondary outcomes included neonatal anaemia,

early respiratory symptoms, polycythaemia, and need for phototherapy. In total, 382 infants

constituted the study population, and their data was analysed according to intention to treat.

From their study, they found out that at 4 months of age, infants showed no significant

differences in haemoglobin concentration between the groups, but infants subjected to

delayed cord clamping had 45% (95% confidence interval 23% to 71%) higher mean ferritin

concentration (117 μg/L v 81 μg/L, p < 0.001) and a lower prevalence of iron deficiency (1

(0.6%) v 10 (5.7%), p = 0.01, relative risk reduction 0.90; number needed to treat=20 (17 to

67)). As for secondary outcomes, the delayed cord clamping group had lower prevalence of

neonatal anaemia at 2 days of age (2(1.2%) v 10 (6.3%), p = 0.02, relative risk reduction

0.80, number needed to treat 20 (15 to 111)). There were no significant differences between

groups in postnatal respiratory symptoms, polycythaemia, or hyperbilirubinaemia requiring

phototherapy. They therefore concluded that delayed cord clamping, compared with early

11

clamping, resulted in improved iron status and reduced prevalence of iron deficiency at 4

months of age, and reduced prevalence of neonatal anaemia, without demonstrable adverse

effects.

The strength of this study laid in the fact that it is one of the largest randomized

controlled studies comparing delayed and early cord clamping in full term infants, and the

first to assess effects on iron status beyond the neonatal period in a high income country.

One limitation of the study was that it was not possible to measure the amount of

blood actually transfused from the placenta into the newborn child. Another limitation was

that the study included only full term, low risk deliveries by healthy mothers from a well

nourished population. The findings may not be generalisable to term infants with various

perinatal risk factors such as maternal diabetes or intrauterine growth restriction.

The findings from this study are supported by results from the studies by Grajeda et

al, Gupta and Ramji, and Chaparro et al. Although these were studies carried out in low and

middle income populations, this study also showed that delayed cord clamping could be

beneficial in high income countries.

Emhamed56 et al., 2004 in a randomized controlled trial to evaluate the early effects

of delayed cord clamping in term neonates born to Libyan mothers. One hundred and four

mother-baby pairs were randomly assigned into early (n=46) cord clamping (within 10

seconds after delivery) or delayed (n=58) cord clamping (after the cord stopped pulsating). At

baseline, the groups had similar demographic and biomedical characteristics, except for a

difference in maternal haemoglobin, which was significantly higher in the early clamping

group (11.7 g/dL (SD 1.3) versus 10.9 g/dL, (SD 1.6); P = 0.0035). Twenty-four hours after

delivery the mean infant haemoglobin level was significantly higher in the delayed clamping

group (18.5 g/dL versus 17.1 g/dL; p = 0.0005). No significant differences were found in

clinical jaundice or plethora. Surprisingly, blood analysis showed that two babies in the early

clamping group had total serum bilirubin levels (>15 mg/dL) that necessitated phototherapy.

There were no babies in the delayed clamping group who required phototherapy. Three

babies in the delayed clamping group had polycythaemia without symptoms, for which no

partial exchange transfusion was necessary.

They therefore concluded that delaying cord clamping until pulsations stop increases

the red cell mass in term neonates. It is a safe, simple and low cost delivery procedure that

should be incorporated in integrated programmes aimed at reducing iron deficiency anaemia

in infants in developing countries.

12

Ceriani Cernadas36 et al., 2006 conducted a study to evaluate the effect of timing of

cord clamping on neonatal venous haematocrit values and clinical outcome at term. It was a

randomized controlled trial performed in 2 Obstetrical units in Argentina on neonates born at

term without complications to mothers with uneventful pregnancies. They randomly assigned

newborns into cord clamping within the first 15 seconds (group 1), at 1 minute (group 2), or

at 3 minutes (group 3) after birth. The baby’s venous haematocrit value was measured 6

hours after birth.

Two hundred and seventy-six newborns were recruited, and mean venous haematocrit

values at 6 hours of life were 53.5% (group 1), 57.0% (group 2), and 59.4% (group 3).

Statistical analyses were performed, and results were equivalent among groups because the

haematocrit increase in neonates with late clamping was within the prespecified physiologic

range. The prevalence of haematocrit at <45% (anaemia) was significantly lower in groups 2

and 3 than in group 1. The prevalence of haematocrit at >65% was similar in groups 1 and 2

(4.4% and 5.9%, respectively) but significantly higher in group 3 (14.1%) versus group 1

(4.4%). There were no significant differences in other neonatal outcomes and in maternal

postpartum haemorrhage.

They concluded that in term newborns, cord clamping at 1 or 3 minutes after birth

resulted in an increase of venous haematocrit levels measured at 6 hours, within physiologic

ranges, and a decreased prevalence of neonatal anaemia without any harmful effect in

newborns or mothers. This practice has been shown to be safe and should be implemented to

increase neonatal iron storage at birth.

The findings from this study was in agreement with the findings from the study by

Emhamed et al., Though both studies were looking at the early effects of delayed cord

clamping on neonatal outcomes at term as their primary outcomes, there were variations in

what constituted delayed cord clamping in both studies. The study by Emhamed et al was a

two arm study with cord clamping done after the cord stopped pulsating while the study by

Ceriani Cernadas et al was a three arm study with delayed cord clamping done at 1 and 3

minutes.

A limitation of the study is that, given the characteristic of the intervention, the

physician in charge of the intervention (umbilical cord clamping) could not be blinded.

However, the health professionals who made the neonatal evaluations after birth and the

personnel in charge of the biochemical tests were blinded to the group assignment.

Jaleel R57 et al., 2009 in a study to determine the effect of delayed umbilical cord

clamping on haemoglobin (Hb) and bilirubin levels of neonates, and to identify newborn

13

babies with anaemia and refer them for treatment, randomly allocated patients admitted into

the labour ward into 2 groups. Group A included women in whom the umbilical cord was

clamped immediately after birth. In Group B, clamping was delayed until cessation of

pulsations in the cord. After cutting the cord, blood sample was obtained from the cut end of

the cord of the newborn for Hb and bilirubin. After 6 hours of birth, another blood sample

was obtained from the antecubital vein for serum bilirubin.

They recruited 200 women, 100 in each group. The mean maternal Hb was 9.75g/dl in

group A and 9.95 g/dl in group B. The average neonatal Hb was 14.1 g/dl in group A and

15.2 g/dl in group B (p = 0.008). In all, 49% of neonates in group A and 37% in group B had

Hb <14 g/dl. Serum bilirubin values at birth and at 6 hours of birth were 1.8 mg/dl and 2.5

mg/dl for group A and 1.9 mg/dl and 2.7 mg/dl for group B respectively. The difference in

bilirubin after 6 hours in the 2 groups was insignificant (p = 0.186)

They concluded that delayed cord clamping in term newborn babies, results in an

increase in haemoglobin, without causing unacceptable side effects, and it can be used as a

simple and cost free intervention for reducing the prevalence of anaemia in infants in

developing countries.

The finding from this study was consistent with findings by Ceriani Cernadas et al,

and Emhamed et al.

Based on the literature reviewed, there is considerable evidence demonstrating the

benefits of delaying cord clamping in term neonates. Delayed cord clamping seems to drive

up mean haematocrit values and serum concentrations of bilirubin, without increasing the

number of babies needing treatment for jaundice or polycythaemia.39

Early cord clamping does not benefit mothers or babies and may even be harmful.

In Nigeria, most tertiary institutions still practice early cord clamping despite weight of

current evidence demonstrating the benefits of delayed cord clamping especially in term

neonates in developing countries. As yet, there is no published local data demonstrating the

effect of timing of umbilical cord clamping in term neonates.

This study hopes to generate a local data, and also to find out whether the result obtained

would be in agreement with the mounting evidence that delayed cord clamping benefits term

neonates.

14

2.5 JUSTIFICATION

Numerous studies have confirmed that delayed umbilical cord clamping at birth

enhances red cell mass and improves iron status during infancy.4,13,57,58

Since many children living in less developed countries such as ours belong to anaemia risk

group, an effective intervention is therefore needed to improve child survival.

Delayed cord clamping is a simple, cost-free and safe delivery procedure that might

offer a sustainable strategy to reduce the risk of early infant anaemia when other interventions

are not yet feasible.

This study might help in the review of the timing of umbilical cord clamping in our

environment.

15

CHAPTER THREE

3.0 GENERAL OBJECTIVE

To determine the haematological and clinical effects of delayed umbilical cord

clamping in term neonates 24 hours after birth at the Federal Medical Centre, Abeokuta

3.1 SPECIFIC OBJECTIVES

1. To evaluate the effect of delayed cord clamping on haematocrit level at 24 hours of life.

2. To determine the effect of delayed cord clamping on bilirubin level at 24 hours of life.

3. To assess the effect of delayed cord clamping on neonatal morbidity (including

polycythaemia, need for phototherapy, and respiratory symptoms)

4. To evaluate the effect of delayed cord clamping on the infant’s haematocrit level at 6

weeks of life

3.2 HYPOTHESIS

10 Delayed cord clamping will not enhance neonatal haematocrit level

1i Delayed cord clamping will enhance neonatal haematocrit level

20 Delayed cord clamping does not increase the risk of neonatal morbidity

2i Delayed cord clamping increases the risk of neonatal morbidity

16

CHAPTER FOUR

4.0 METHODOLOGY

4.1 STUDY DESIGN

A prospective randomized controlled study.

4.2 STUDY AREA

The study was carried out in the labour ward of the Department of Obstetrics and

Gynaecology as well as the neonatal unit of the Department of Paediatrics at the Federal

Medical Centre, Abeokuta.

Abeokuta is the capital city of Ogun state and is located in South-Western Nigeria. It is

situated 74 km north of Lagos along Ogun River and has a population of about 600 000

people with most of its inhabitants being “Egbas”, a sub-group of the Yoruba people.

Abeokuta is made up of two local government areas: Abeokuta North and Abeokuta South.

Federal Medical Centre, Abeokuta is a tertiary health care centre located in Idi-Aba

within Abeokuta South local government area on the outskirts of the city. It has an annual

average delivery rate of 1200 live births per annum.

The department of Obstetrics and Gynaecology consists of seven units: Antenatal, labour and

postnatal wards, gynaecological emergency unit, gynaecological ward, Outpatient clinics and

the Family Planning unit, while the Paediatrics department consists of the neonatal ward,

children’s ward, children’s emergency room, the paediatrics outpatient department, and the

consultant specialist clinics.

4.3 STUDY POPULATION

All pregnant women presenting for vaginal delivery at the Federal Medical Centre,

Abeokuta during the study period, who met the inclusion criteria. The hospital offers

obstetric services to the Abeokuta community and its environs. The patients are mainly civil

servants, teachers, traders and a minority being farmers. They belong to two main religions,

Christianity and Islam though a few are traditionalists.

17

4.3.1 INCLUSION CRITERIA

Women with uncomplicated, singleton, term pregnancy (gestational age 37+0 to 41+6)

determined by LMP or early USS who were admitted into the labour ward for vaginal

delivery during the study period, and who gave consent for the study.

4.3.2 EXCLUSION CRITERIA

1. Rhesus negative blood group

2. HBsAg positive women

3. HIV positive women

4. Multiple pregnancy

5. Severe antepartum haemorrhage

6. Gestational diabetes mellitus

7. Preeclampsia

8. Intrauterine growth restriction

9. Instrumental delivery

10. Need for early cord clamping (tight nuchal cord, resuscitation)

11. Major congenital abnormality (NTDs)

12. Infants weighing <2.5kg

Criteria 1 to 8 were applied before randomization while criteria 9 to 11 were applied after

randomization.

4.4 SAMPLE SIZE DETERMINATION

The sample size for the study was calculated using the formula for comparison of two

means.59

n = (u + v) 2 (σ1 2 + σ0

2 )

(μ1 – μ 0) 2

Where,

n = minimal sample size per group

u = standard normal deviate corresponding to the probability of making type II

error (β) of 20%. Power at 80% = 0.84

v = standard normal deviate corresponding to the probability of type I error (α) at 5% =

1.96

18

σ0 = standard deviation of heamatocrit level after 24 hours in control group in a previous

study by Emhamed et al56 = 5.7

σ1 = standard deviation of haematocrit level after 24 hours in the intervention

group in a previous study by Emhamed et al56 = 6.3

μ1 – μ 0 = difference between the means in haematocrit level between the two groups

= 3.6

n= (0.84 + 1.96)2 (6.32 + 5.72)

(52.9 – 49.3)2

n = (7.84) (39.69 + 32.49)

(3.6)2

n = 43.6 ≈ 44

Therefore, the minimum sample size in each group was 44

For the two groups, total sample size = 44 + 44 = 88

For an attrition rate of 20%, adjustment factor =

100____ = 1.25

100 – 20

Therefore, desired sample size was

1.25 x 88 = 110

Hence, a minimum of 110 participants was required for statistical inference.

19

4.5 STUDY PROCEDURE

Pregnant women were given information about the study at the antenatal clinic by the

investigator. Those who fulfilled the inclusion criteria who presented for vaginal delivery at

the labour ward following spontaneous onset of labour, or those planned for induction of

labour, were again informed about the study by the investigator or the resident doctor

assigned to do so and informed consent was obtained.

Eligible participants were randomly assigned into either of the two groups; delayed

cord clamping (intervention) group and the early cord clamping (control) group.

Randomization was achieved by a computer generated random number list between 1

and 110. All 55 numbers generated by the computer were assigned to the delayed cord

clamping (intervention) group, while the remaining 55 numbers were assigned to the early

cord clamping (control) group. The numbers from 1 to 110 were written on pieces of paper

and placed in a large brown opaque envelope from where each woman drew from until

completion of the study. The numbers generated by the computer which belonged to the

intervention group were written boldly on cardboard paper and placed in the labour ward for

easy identification by the attending doctor or midwife.

Before delivery, a semi structured pretested questionnaire was used to obtain socio-

economic and demographic details from the mother as well as information on reproductive

health.

The delivery was supervised or conducted by the investigator, the designated

registrar, or midwife who had been fully briefed on the methodology of delayed cord

clamping.

Following delivery, the babies were placed on a draped adjustable trolley, distal to the

mother’s perineum, and adjusted to be at par with the level of the uterus. The babies were

dried and wrapped in warm linen to prevent hypothermia, and remained in this position until

the cord was clamped.

For the patients randomized into the DCC group, the umbilical cord was double

clamped and cut between clamps at two minutes. The exact time was recorded by the use of a

stopwatch, by the research assistant and it was measured as the time from complete expulsion

of the fetus to the first clamp on the umbilical cord.

Those randomized into the ECC group, had clamping done within 10 seconds after

delivery, which is the routine standard of care at the centre. Ten international units of

oxytocin was administered to the mother intramuscularly or intravenously if she had an

20

intravenous canula in-situ after cord clamping. Labour and delivery were conducted

following the standard practice of care.

At 24 hours of life, blood was obtained from the dorsum of the hand of the baby after

cleaning with methylated spirit, for the estimation of venous haematocrit and serum bilirubin.

Blood was collected in 2 heparinised capillary tubes which was sealed at one end with

modelling clay and centrifuged for 5 minutes using HaematoSpin 1400 (Hawksley, England).

Haematocrit estimation was done using the Micro-Haematocrit reader (Hawksley, England)

at the side laboratory by the designated registrar in the labour ward. The side laboratory is

fully operational on a 24 hour basis, and at all times, the designated registrar in the labour

ward was informed about the time of sample collection which was boldly written on a white

sticker attached to the patient’s case note.

The estimation of serum bilirubin was done by obtaining 4 ml of blood in Lithium

Heparin vacuum tube and analysed using the RANDOX BILIRUBIN kit which employs the

colorimetric method based on that described by Jendrassik and Grof (1938). The samples for

bilirubin estimation were centrifuged immediately after collection at 4000g for 15 minutes,

and the supernatant was carefully collected using a disposable plastic pipette and placed in

plain sample bottles. The sample bottles were placed in a small brown envelope (to protect

them from light) and stored in the refrigerator at 4-80C and analysed within 24 hours of

separation. The analysis was carried out in the hospital laboratory by the designated

laboratory scientist.

All the babies were examined by the paediatric resident at birth, and 24 hours post

delivery for clinical signs of hyperviscosity syndrome, hyperbilirubinaemia and

polycythaemia.

All the baby’s anthropometric measurements (weight and length) were obtained using

the Salter 15kg-50g model 180 baby weighing scale and an infantometer respectively.

Before discharge, an assessment of gestational age was completed by the Ballard-external

method.60 This was done by the paediatric resident.

All neonatal diagnoses as well as the outcome variables were recorded in the data sheet.

Neonatal anaemia was defined as a venous haematocrit level of <45%, polycythaemia as

venous haemantocrit of >65%, hyperbilirubinaemia as bilirubin >10 mg/dL at 24 hours of

life, clinical jaundice as yellowness of the sclera and/or skin and neonatal tachypnoea as

respiratory rate > 60/ minute.

21

Given the characteristics of the intervention, the accoucheur was not blinded. However, the

paediatrician performing neonatal examinations as well as the registrar and laboratory staff

performing analysis of blood samples were blinded to each baby’s allocation group.

The babies were scheduled for a follow-up visit at the postnatal clinic after 6 weeks,

where venous blood sample for haematocrit, weight and length measurements were obtained

and recorded on the data sheet.

4.5.1 DATA COLLECTION INSTRUMENT

A semi structured pretested questionnaire was used to obtain information from eligible

participants. The questionnaire was divided into the following sections:

Section A: Socio-demographic information

Section B: Antenatal care information

Section C: Reproductive Health

4.5.2 ANALYSIS OF DATA

Data obtained at the end of the study was processed using SPSS version 19.

Quantitative variables were presented using means and standard deviations, categorical

variables were presented using proportions. Associations was tested using chi squared test

and Student’s t test for categorical and continuous variables respectively. Significance level

was set at 5%.

Data analysis was done by the researcher with the assistance of a medical statistician

and findings were compared with those of previous studies.

4.6 ETHICAL CONSIDERATION

Ethical permission to carry out the study was sought from the hospital’s Health

Research Ethics Committee (HREC) before the commencement of the study.

4.6.1 INFORMED CONSENT

Detailed information, explanation and nature of the study was offered to every

woman found to be eligible for the study and an informed consent was obtained. Each

participant was given the opportunity to ask questions about the study and appropriate

answers were provided.

The informed consent was translated into the local language and read to every

prospective participant in the language she understood.

22

4.6.2 CONFIDENTIALITY OF DATA

The participants were assured of the confidentiality of the data and access to study

data was made available only to study personnel.

4.6.3 BENEFICIENCE TO PARTICIPANTS

The study is hoped to be beneficial to patients in the long run as it seeks to prevent or

slow the onset of iron deficiency by increasing the infant’s iron endowment at birth.

4.6.4 NON-MALFICENCE TO PARTICIPANTS

The study was not in any way harmful to the participants

4.6.5 RIGHT TO DECLINE/WITHDRAWAL FROM THE STUDY

Participants were assured of their right to decline or withdraw from the study at

anytime and following their withdrawal, they were not denied any benefit or care.

4.6.7 FUNDING FOR THE STUDY

The funding for the study was provided solely by the researcher

4.6.8 QUALITY ASSURANCE

The objectives and methodology of the study was clearly explained and discussed at a

stakeholders meeting involving the researcher, doctors and nurses working in the labour

ward, post-natal ward as well as the neonatal unit, and the laboratory scientist.

The data sheet was introduced to the doctors who were involved in filling them.

4.7 DISSEMINATION OF FINDINGS

The findings of the study will be disseminated by submission of the dissertation to the

National Postgraduate Medical College of Nigeria for the part II Fellowship Examination in

the Faculty of Obstetrics and Gynaecology and within the Department of Obstetrics and

Gynaecology, Federal Medical Centre, Abeokuta.

It will also be published in a peer reviewed journal in conjunction with the

supervising consultants.

23

CHAPTER FIVE

5.0 RESULTS

During the study period, a total of 110 mother-infant pairs who met the eligibility

criteria for the study were counselled and consented for the study. Fifty-five mother-infant

pairs were randomized into the early cord clamping (ECC) group and another 55 into the

delayed cord clamping (DCC) group.

A total of 11 (10%) mother-infant pairs (7 from the ECC group and 4 from the DCC

group) did not turn up for the follow up visit at the post-natal clinic and were thus excluded

from the analysis.

As a result, 48 (43.6%) mother-infant pairs remained in the ECC group and 51 (46.4%) in the

DCC group.

Table I shows the maternal characteristics. The mean (SD) age of mothers in the ECC group

was 31.3 (4.5) years while that of mothers in the DCC group was 31.0 (4.2) years (t = 0.34, df

= 97, p = 0.732). There was no statistically significant age difference between the two groups.

Most of the women in both groups were < 35 years, accounting for thirty-eight (79.2%) and

39 (76.5%) in the ECC and DCC groups respectively. None of the mothers was a teenager.

Many of the women were multiparous 65 (65.7%), while 34 (34.3%) were primipara.

Of the multiparous women, only one (1.0%) woman was grand-multipara and she belonged

to the DCC group. Majority of the mothers 86 (86.9%) had tertiary level of education; 41

(85.4%) for the ECC group and 45 (88.2%) for the DCC group. Only 3 (3.0%) participants

had none or primary level of education.

The mean (SD) prepartal haematocrit was significantly higher in the ECC group

39.9% (3.3) than in the DCC group 36.8% (4.1); (t = 4.13, df = 97, p = 0.0001)

The mean (SD) number of ANC visits was found to be similar for both groups; 6.3

(2.4) for the ECC group and 6.4 (2.7) in the DCC group.

The mean (SD) EBL was 187.5ml (74.7) and 201.6ml (72.7) for the ECC and DCC

groups respectively. Although the mean EBL in the DCC group was higher than that in the

ECC group, this was not statistically significant. (t = 0.95, df = 97, p = 0.344). None of the

participants had primary post-partum haemorrhage.

Table II shows the baseline characteristics of the babies. The mean (SD) gestational

age of babies in the ECC group was 39.7 weeks (1.1) while that of babies in the DCC group

was 39.2 weeks (1.2); (t = 2.16, df = 97, p = 0.033)

The sex distribution of the babies showed that there were more males in the ECC

group compared with the DCC group which had more females.

24

The mean (SD) apgar score at the first minute of life revealed that babies in the DCC

group had higher apgar scores compared with babies in the ECC group; 8.4 (0.7) vs 7.8 (1.1).

This difference was statistically significant; (t = 3.26, df = 97, p = 0.002)

The mean (SD) birth weight of babies in the ECC group was 3050g (329), and that of

babies in the DCC group was 3150g (426). This did not differ significantly; (t = 1.30, df = 97,

p = 0.196). Likewise, the birth length of babies in both groups did not differ significantly.

The mean (SD) birth length of babies in the ECC group was 48.7 cm (1.8) and 49.2 cm (2.6)

for babies in the DCC group; (t= 1.11, df = 97, p = 0.271).

Table III shows the haematological outcome at 24 hours of life. At 24 hours of life,

the mean (SD) haematocrit level for babies in the ECC group was 44.8% (5.0) while for

babies in the DCC group it was 56.5% (6.0). The higher mean haematocrit level in the DCC

group compared with the ECC group was statistically significant. (t = 10.51, df = 97, p =

0.000).

Twenty-two (45.8%) babies in the ECC group and two (3.9%) babies in the DCC

group had anaemia (hct < 45%). The higher proportion of babies with anaemia in the ECC

group was statistically significant; (χ2 = 21.424, df = 1, p = 0.000).

Although six (11.8%) babies in the DCC group had polycythaemia (hct > 65%), none

was seen in the ECC group, and all were asymptomatic. This difference was also statistically

significant (χ2 = 4.123, df = 1, p = 0.042).

Table IV shows the neonatal secondary outcomes. The mean (SD) serum bilirubin

value at 24 hours of life was 4.7mg/dl (2.0) in the ECC group and 5.5mg/dl (1.9) in the DCC

group. The higher mean serum bilirubin in the DCC group compared with the ECC group

was statistically significant; (t = 2.04, df = 97, p = 0.044). There were no statistically

significant differences in the proportion of babies with clinical jaundice in both groups and

the number of babies that required phototherapy did not differ significantly. Although, it was

observed that a higher proportion of babies in the ECC group 16 (33.3%) compared with the

DCC group 12 (23.5%) developed clinical jaundice. This was not statistically significant; (χ2

= 1.172, df = 1, p = 0.279). One (2.0%) baby in the DCC group required EBT. The baby was

also found to have ABO incompatibility.

As shown in table IV, there was no statistically significant difference in the number of

babies that were tachypnoeic (RR > 60) in both groups. Six (12.5%) babies in the ECC group,

and five (9.8%) babies in the DCC group were tachypnoeic at 24 hours of life; (χ2 = 0.182, df

= 1, p = 0.670). Only one (2.1%) baby in the ECC group developed respiratory distress.

25

A total of six (6.1%) babies, three (5.9%) from the DCC group and three (6.3%) from the

ECC group were admitted to NICU. The mean (SD) length of hospital stay was 2.7 days (2.0)

in the ECC group and 2.4 days (1.2) in the DCC group. No statistically significant difference

was observed in the mean length hospital stay in either group; (t = 0.91, df = 97, p = 0.364)

At 6 weeks of life, as shown in table V, the mean (SD) haematocrit level was 32.0%

(3.1) in the ECC group and 34.9% (5.2) in the DCC group. The higher mean haematocrit

level in the DCC group compared with the ECC group was statistically significant. (t = 3.34,

df = 97, p = 0.001).

Although more babies in the ECC group 9 (18.8%) compared with 4 (7.8%) in the DCC

group had a haematocrit < 30% at 6 weeks of life, this difference was not statistically

significant; (χ2 = 1.711, df = 1, p = 0.191).

There was no significant difference in the mean (SD) weights of the babies at 6 weeks in both

groups; 4.9 kg (0.8) in the DCC group vs 4.7 kg (0.7) in the ECC group; (t = 1.32, df = 97, p

= 0.190).

26

Table I. Maternal characteristics

Variable Early clamping

group (n=48)

Delayed clamping

group (n=51)

p-value

Age (years)

<35 38 (79.2) 39 (76.5) 0.747

≥35 10 (20.8) 12 (23.5)

Parity (including study child)

Primipara 15 (31.2) 19 (37.3) 0.486

Multipara 33 (68.8) 31 (60.8)

Grand multipara 0 (0) 1 (1.9)

Educational level

None or primary 1 (2.1) 2 (3.9) 0.661

Secondary 6 (12.5) 4 (7.8)

Tertiary 41 (85.4) 45 (88.3)

Prepartal haematocrit (%)

<30 2 (4.2) 1 (2.0) 0.957*

≥30 46 (95.8) 50 (98.0)

Number of antenatal visits

<4 6 (12.5) 7 (13.7) 0.857

≥4 42 (87.5) 44 (86.3)

Values are numbers (%) * Yates’s correction

Table II. Newborn characteristics

Variable Early clamping

group(n=48)

Delayed clamping

group(n=51)

p-value

Sex

Male 26 (54.2) 20 (39.2) 0.136

Female 22 (45.8) 31 (60.8)

Apgar score at 1 min

≥7 45 (93.8) 51 (100) 0.220*

<7 3 (6.2) 0 (0)

Values are numbers (%), * Yates’s correction

27

Table III. Neonatal haematological outcome at 24 hours of life

Variable Early clamping

group(n=48)

Delayed clamping

group (n=51)

p-value

Haematocrit (%)

>65(polycthaemia) 0 (0) 6 (11.8) 0.0001

45-65 26 (54.2) 43 (84.3)

<45(anaemia) 22 (45.8) 2 (3.9)

Values are numbers (%)

28

Table IV. Neonatal secondary outcomes

Variable Early clamping

group (n=48)

Delayed clamping

group (n=51)

p-value

Serum bilirubin at 24 hrs

(mg/dl)

≥10 1 (2.1) 1 (2.0) 1.000*

<10 47 (97.9) 50 (98.0)

Clinical jaundice

yes 16 (33.3) 12 (23.5) 0.279

no 32 (66.7) 39 (76.5)

Phototherapy

yes 2 (4.2) 3 (5.9) 1.000*

no 46 (95.8) 48 (94.1)

EBT

yes 0 (0) 1 (2.0) 1.000*

no 48 (100) 50 (98.0)

Respiratory rate at 24 hrs

>60 6 (12.5) 5 (9.8) 0.670

≤60 42 (87.5) 46 (90.2)

Respiratory distress

yes 1 (2.1) 0 (0) 0.976*

no 47 (97.9) 51 (100)

NICU admission

yes 3 (6.3) 3 (5.9) 1.000*

no 45 (93.7) 48 (94.1)

Mean length of hospital stay

in days (SD)

2.7 (2.0) 2.4 (1.2) 0.364

Values are numbers (%) unless otherwise stated, * Yates’s correction

29

Table V. Haematocrit at 6 weeks of life

Early clamping

group (n=48)

Delayed clamping

group (n=51)

p-value

Mean (SD) 32.0 (3.1) 34.9 (5.2) 0.001

Minimum-maximum 26.0 - 40.0 25.0 - 50.0

30

5.1 HYPOTHESIS TESTING

Hypothesis 1

The alternate hypothesis that delayed cord clamping will enhance neonatal haematocrit level

was hereby accepted based on a p-value of 0.0001 which was found to be statistically

significant.

Hypothesis 2

The null hypothesis that delayed cord clamping does not increase the risk of neonatal

morbidity was hereby accepted because there was no statistically significant difference in the

risk of neonatal morbidity.

31

CHAPTER SIX

6.0 DISCUSSION

This prospective randomised controlled study was done to determine the effect of a

two minute delay in umbilical cord clamping of term neonates on haematocrit level, and the

risk of morbidity 24 hours after birth at the Federal Medical Centre, Abeokuta. The study also

went further to evaluate the effect of delayed cord clamping on the infant’s haematocrit level

at 6 weeks postpartum.

Most of the mothers in the study were less than 35 years, mostly multiparous and

majority had a tertiary level of education reflecting the young dynamic nature of the

population and the emphasis placed on education in South West Nigeria.

Although the mean prepartal haematocrit was significantly higher in the ECC group

compared with the DCC group, there were no significant differences in the other

demographic and biomedical variables of women between the two groups. This is similar to

the finding in the study by Emhamed56 et al in Libya.

However, in their study, they found a significantly higher number of women with

anaemia in the DCC group compared with the ECC group on admission to labour room. In

the present study, only 3 women had anaemia upon admission into labour ward (2 women in

the ECC group and 1 woman in the DCC group). This reflects the emphasis placed on routine

PCV checks during the ANC clinic and correction of anaemia prior to delivery. It may also

be a reflection on the level of adherence to routine haematinics during ANC.

The study found a significant increase in the mean neonatal haematocrit value at 24

hours of life of babies in the DCC group compared with babies in the ECC group. This

finding was consistent with that of Emhamed56 et al, Ceriani Cernadas36 et al in Argentina,

van Rheenen53 et al in Zambia, Andersson O55 et al in Sweden, Chaparro54 et al in Mexico

and Jaleel R57 et al in Pakistan but different from findings in the study conducted by

Grajeda13 et al in Guatemala, Gupta and Ramji52 in India and Jahazi61 et al in Iran.

In the studies by Emhamed et al and Van Rheenen et al, they found a significantly

higher haematocrit in the DCC group compared with the ECC group after 24 hours. In both

studies, delayed cord clamping was done after caessation of cord pulsation at an average of

3.5 and 5 minutes respectively. In this study, delayed clamping was done at 2 minutes. Both

studies looked at the early haematological effects of delayed cord clamping as was done in

the present study.

In the Libyan study, the babies were placed on the mother’s abdomen (above the level of the

placenta), while in the Zambian study, the babies were placed 10 cm below the vaginal

introitus (below the level of the placenta). In the present study, babies were placed at the

32

same level as the placenta. This shows that the level of the newborn after delivery does not

significantly influence haematocrit value in the first 24 hours.

Andersson O et al, in their study which was conducted in a high income country, also found a

significantly higher haematocrit level in the DCC group at a median age of 2.4 days. Ceriani

Cernadas et al as part of their secondary outcome measures looked at heamtocrit value at 24

to 48 hours and also found a significantly higher haematocrit in the DCC group at 1 and 3

minutes. Theirs was a 3-arm study with delayed clamping done at 1 and 3 minutes. Both

studies included eligible mothers that had vaginal delivery as well as caesarean section. The

present study was limited to vaginal deliveries only.

Chaparro et al and Jaleel et al also found a significantly higher haematocrit/haemoglobin

value in the DCC group at 4-8 hours after birth.

The study by Gupta and Ramji did not find a significant difference in the haemoglobin value

of newborn at birth, while Grajeda et al did not find a significant difference in haematocrit

value at 24 hours between the two groups.

In the Indian study, though delayed cord clamping was done after decent of the

placenta into the vagina, with the newborn held below the level of the placenta, haemoglobin

estimation at birth was done using cord blood sample which may be responsible for the lack

of significant difference. Studies have shown that cord blood haematocrit is not affected by

placental transfusion.62 In the present study, sample for haematocrit estimation was obtained

after 24 hours from the dorsum of the hand of the baby.

In the Guatemalan study, the lack of a significant difference in haematocrit value at

24 hours may be attributed to the method of randomization. The study population consisted

of 3 groups, and randomization was done by day of the week, that is, a different delivery

method was used per day so that each treatment was repeated every third working day. Also,

venous sample for haematocrit estimation was obtained from a subset of babies (the last 41

recruited into the study). This may not have given every baby an equal chance of being

selected compared to the present study in which randomization was achieved by a computer

generated random number list, thus every baby had an equal chance of being selected.

Jahazi et al in Iran also did not find a significant difference in haematocrit value at 2

and 18 hours of life. In their study, early cord clamping was done at 30s compared with < 10s

in the present study. This timing might have enhanced placental transfusion as placental

transfusion is said to occur when cord clamping is delayed for at least 5s7.

The proportion of babies with anaemia at 24 hours was significantly higher in the

ECC group compared with the DCC group. This finding was consistent with studies done by

Andersson O et al and Ceriani Cernadas et al. This might be related to the high prevalence of

33

maternal iron deficiency in our environment which has also been reported in high income

countries.63 The study by Jaleel et al in Pakistan did not show a significant difference in the

proportion of babies with anaemia in either group. The observed lack of difference might be

due to the use of cord blood which was obtained at birth for the estimation of haemoglobin.

However, in the present study, venous blood sample obtained from the dorsum of the hand of

the baby after 24 hours was used for the estimation of haematocrit.

In the present study, the mean serum bilirubin at 24 hours was significantly higher in

the DCC group compared with the ECC group. This finding was different from that

documented by Andersson O et al, Ceriani Cernadas et al, Emhamed et al, and Jaleel et al; all

of which found no significant difference in total bilirubin value in either group, which might

be due to the different techniques employed in the assessment of serum bilirubin.

However, no significant differences were observed in the number of babies with

hyperbilirubinaemia and clinical jaundice which were consistent with the studies done by

Chaparro et al, Andersson O et al, Ceriani Cernadas et al, Emhamed et al, and Jaleel et al and

also in agreement with a recent meta-analysis.39

As observed in the present study, six babies had polycythaemia, and none was seen in

the ECC group. None of the babies however were symptomatic. This was consistent with the

Libyan and Mexican studies, but the difference did not reach a significant level for both

studies. Although consistent with the study carried out in Guatemala, this was a 3-arm study,

and the proportion of neonates with polycythaemia was significantly higher in those that had

delayed clamping done with the baby placed below the level of the placenta than in those that

had the baby placed at the same level as the placenta. Babies were placed at the same level as

the placenta in the present study.

No significant differences were observed in the groups with regard to the proportion

of neonates with polycythaemia in the Zambian study which set the cut-off for polycythaemia

as PCV > 70 percent compared with > 65 percent in the present study.

In the present study, no significant differences were observed in the number of babies

that required phototherapy or in the number of babies with respiratory symptoms in either

group which was consistent with the studies done by Ceriani Cernadas et al, and Andersson

O et al.

One baby required EBT in the DCC group, who was discovered to have ABO

incompatibility. No other study documented the need for EBT among babies with delayed

cord clamping. This corroborates the fact that associated morbidities could result in the need

for EBT apart from a high haematocrit level.

34

No significant difference was observed in admission rate to NICU in the present study

as observed in the study done by Ceriani Cernadas et al, the only recent study that reported

this outcome variable.39

Though the length of hospital stay in the present study was longer in the ECC group

compared with the DCC group, it was not statiscally significant. This was consistent with the

Argentinean study.

At the 6th week of life, the haematocrit value of the babies was assessed and it was

observed that babies in the DCC group had a significantly higher haematocrit value compared

to babies in the ECC group. This observed effect was similar to that found at 2 months by

Grajeda et al and at 3 months by Gupta and Ramji.

The findings were inconsistent with the studies conducted by Andersson O et al and

Chaparro et al which found no significant difference in haematocrit value at 4 and at 6

months respectively. However, the Mexican study went ahead to analyse the iron status

(mean corpuscular volume, ferritin, body iron, and stored iron) of the babies at 6 months and

it was found to be significantly higher in the DCC group. The mean ferritin concentration was

also significantly higher at 4 months in the DCC group in the Swedish study. The present

study was only limited to 6 weeks postpartum and the indicators of iron status were not

analysed.

In the present study and as reported in a Cochrane review, there was no significant

difference in the mean postpartum blood loss between the early and delayed cord clamping

groups.29 None of the participants in the present study had primary PPH. Postpartum blood

loss was quantified by visual estimation.

No significant differences were observed in neonatal adverse event rates between the two

groups and no maternal or neonatal mortality was observed in the study population.

Delayed cord clamping in this randomized controlled study improved neonatal

haematocrit value in the first 24 hours of life and at 6 weeks postpartum and it did not

increase the risk of neonatal morbidity.

35

6.1 LIMITATIONS OF THE STUDY

Given the characteristics of the intervention, the mother as well as the resident doctor

or midwife conducting the delivery could not be blinded to the assigned intervention.

Serum ferritin which is the most sensitive indicator of iron status was not assayed for

as was done in other studies because it is not routinely done in the hospital laboratory.

A follow up study for a longer period could not be done in view of the nature of the

timing of the residency training programme.

36

6.2 CONCLUSION

In the present study, it was concluded that

Delaying clamping of the umbilical cord in term neonates for two minutes after

delivery resulted in a higher mean haematocrit value of the newborn in the first 24

hours of life.

Delayed cord clamping resulted in persistence of a high haematocrit value up to 6

weeks postpartum.

Delayed cord clamping resulted in a significant reduction in the proportion of

anaemic neonates and it did not increase the risk of neonatal morbidity.

37

6.3 RECOMMENDATION

Delayed cord clamping is beneficial to babies by enhancing their haematocrit value without

increasing adverse neonatal outcomes.

This practice is safe and should therefore be incorporated into delivery protocols in our

environment to reduce the incidence of neonatal anaemia.

6.4 AREAS OF FURTHER RESEARCH

1. Impact of delayed cord clamping on ABO incompatibility.

2. Delayed cord clamping at caesarean section in view of the rising caesarean section

rate in our environment.

3. Effect of delayed cord clamping on serum ferritin level.

38

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47. Thomas DG, Grant SL, Aubuchon-Endsley NL. The role of iron in neurocognitive

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49. Szajewska H, Ruszczynski M, Chmielewska A. Effect of iron supplementation in

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51. Budin P. At what point should we practice the ligation of the umbilical cord? Progr Med

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52. Gupta R, Ramji S. Effect of delayed cord clamping on iron stores in infants born to anaemic

mothers: A randomized controlled trial. Indian paediatr. 2002;39:130-5

53. Van Rheenen P, de Moor L, Eschbach S, de Grooth H, Brabin B. Delayed cord clamping and

haemoglobin levels in infancy: a randomized controlled trial in term babies. Trop Med Int

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54. Chaparro CM, Neufeld LM, Tena AG, Eguia-Liz CR, Dewey KG. Effect of timing of

umbilical cord clamping on iron status in Mexican infants: A randomized controlled trial.

Lancet. 2006;367:1997-2004

55. Andersson O, Hellstrom-Westas L, Andersson D, Domellof M. Effect of delayed versus early

umbilical cord clamping on neonatal outcomes and iron status at 4 months: A randomized

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56. Emhamed MO, van Rheenen P, Brabin BJ. The early effects of delayed cord clamping in

term infants born to Libyan mothers. Trop Doct. 2004;34:218-22

57. Jaleel R, Deeba F, Khan A. Timing of umbilical cord clamping and neonatal haematological

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58. Rabe H, Reynolds GJ, Diaz-Rossello JL. A systematic review and meta-analysis of a brief

delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93:138-44

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61. Jahazi A, Kordi M, Mirbehbahani NB, Mazloom SR. The effect of early and late umbilical

cord clamping on neonatal haematocrit. J Perinatology. 2008; 28: 523-25.

62. Linderkamp O, Nelle M, KrausM, Zilow EP. The effect of early and late cord clamping on

blood viscosity and other hemorheological parameters in full-term neonates. Acta paediatrica

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43

APPENDIX I

OUTCOME OF DELAYED CORD CLAMPING IN TERM NEONATES

AT THE FEDERAL MEDICAL CENTRE, ABEOKUTA.

CONSENT FORM (ENGLISH)

Dear Ma,

My name is Dr Awolaja Babatunde Stephen. I am a senior registrar in the Department

of Obstetrics and Gynaecology. The main purpose of this study is to find out if tying the

umbilical cord of babies born at term after waiting for 2 minutes has any effect on their blood

level and other blood characteristics at the Federal Medical Centre, Abeokuta.

There is no fixed rule regarding the most favourable timing for tying the cord.

Various studies have shown that waiting for sometime before tying the cord can be of benefit

to the infant by improving iron status especially in a developing country like ours where

shortage of blood due to iron deficiency is prevalent.

If you wish to take part in this study, you will be asked some questions and some

other information concerning you will be obtained and recorded in my data sheets.

After meeting the criteria to participate in the study, you will be placed in either of

two groups; the delayed cord clamping (intervention) group or the early cord clamping

(control) group. If you fall into the intervention group, after delivery of your baby, a delay of

2 minutes would be observed before tying the umbilical cord. While if you fall into the

control group, the umbilical cord would be tied within 10 seconds of delivery as it is

routinely practised in the hospital.

All of your information will be kept confidential to the extent required by the law and

your personal identity will not be revealed in any publication or release of results.

Your decision to join in this study is voluntary and you may wish to quit at any time, and if

you quit, you will not be denied any benefit or care.

For more information, you may call the researcher Dr. Awolaja Babatunde Stephen on this

line 0803 291 1203.

44

Investigator's Statement

I have provided an explanation of the above research program. The participant was given an

opportunity to discuss the study. A copy of the consent form has been given to the participant

for attestation.

_______________________________ __________

Signature of Investigator or Interviewer Date

Participant’s Statement

I,.............................................................................. certify that I have read, had read or it had

been translated to me the components of the study and I understand the description of this

study. I have asked and received answers to all my questions about the study. I voluntarily

consent to join the study. I understand that I may quit the study at any time. I understand that

I may ask further questions at any time. I have had an opportunity to carefully review the

consent form and asked questions about it.

___________________________________ __________

Signature/ Left Thumb Print of Participant Date

___________________________________ __________

Signature of Translator Date

(Where the patient does not speak English, to be done by someone that speaks the same

language as the patient)

___________________________________ __________

Signature of Witness Date

45

APPENDIX I

ABAJADE ESI LORI ITESEDURO IDAWOO OMO TITUN NI ILE IWOSAN

FEDERAL MEDICAL CENTRE, ABEOKUTA.

CONSENT FORM (YORUBA)

Mama mi tooto,

Oruko mi ni Onisegun Oyinbo Awolaja Babatunde Stephen. Moje olugbaniwole agba ni eka

eto iloyun ati ibimo. Koko ise iwadii yi ni lati mo boya siso iwo omo fun bi iseju meji, ni ipa

Kankan ko lori ipo eje omo ati irisi miiran lori eje ni ile iwosan Federal Medical Center,

Abeokuta.

Kosi ilana kan pato nipa ona ti o dara ju lori wiwo agogo fun didawoo. Opolopo lwadii ti fi

han pe diduro fun igba die ki a to so iwo le je anfaani fun omo owo lati le se daradara lori

ilera won paapaa julo ni awon ilu ti idagbasoke ti ba bii tiwa ti o ni isoro aito eje.

Ti e ba nifee lati kopa ninu ise iwadii yii, a o beere awon ibeere ati awon ohun to ye lati mo

nipa re ni a o gba a,ti a o si ko o sile sinu iwe iwadi mi.

Leyin ti o ba ti yege atikopa ninu ise iwadii naa, a o fi o si okan ninu awon owo meji,

iteseduro idawo (idasi), owo kin-in-ni tabi owo keji itete dawoo(akoso). Ti a ba bo si owo

idasi, lehin ibimo re iteseduro iseju meji yoo waye ki a to ta iwo ni koko. Ti o ba si je owo

akoso ni o bo si, a o ta koko iwo naa laarin iseju winiwini mewaa ti o ba bimo tan gege bi

won ti n se nile iwosan.

Gbogbo asiri iwadi re ni yoo wa ni pipamo gege bi ofin se laa kale ati pe aami idanimo re ko

ni han sita ninu abajade tabi se afihan re ninu abajade esi.

Ipinu re lati kopa ninu ise iwadii yii kokon dandan, ati pe o le kuro ni igba-kugba.

Fun mimo si nipa ise yii, o le pe aago Oluwadii Onisegun Oyinbo Awolaja Babatunde

Stephen sori ero ibanisoro yi 08032911203

46

Oro Oluwadi

Mo ti se alaye lori eto iwadii oke yii. Awon akopa si ni anfaani lati soro lori ise naa.

Iwe ifohunsokan si ti lo si odo akopa gege bi eri

_______________________________ _______________________

Ibowoluwe oluwadi/Aforowanilenuwo Ojo

Oro Olukopa

Emi,---------------------------------------------------- jejee pe mo ti kaa/won si ti se ogbufo

ohun ti ise naa dale fun mi, mo si gbo agboye re. Mo ti beere gbogbo ibeere, mo si ti gbo

idahun re lori ise iwadi naa. Ifinufedo mi ni mo fi darapo mo ise iwadii naa. Mo si mo pe mo

le yeba (Kuro) nigbakugba ti o ba wun mi. Mo si mo pe mo le beere ibeere siwaju sii ni

igbakungba. Mo mo pe mo ni igbalaaye lati se atunse lori iwe ifohunsokan ati lati beere

ibeere lori re.

____________________________ ________________________

Ibowoluwe/Iteka Owo Osi Akopa Ojo

____________________________ _________________________

Ibowoluwe Ogbufo Ojo

(Ti alaisan ko ba le so ede Geesi ki eni ti o gbo ede alaisan se e)

_____________________________ _______________________

Ibowoluwe Olujerii Ojo

47

APPENDIX I

OUTCOME OF DELAYED CORD CLAMPING IN TERM NEONATES AT THE

FEDERAL MEDICAL CENTRE, ABEOKUTA.

CONSENT FORM (IGBO)

Ezigbo Nne,

Aham bu Dokita Awolaja Babatunde Stephen. Abum, Registra ukwu na Departmenti

nke Obstetrics na Gynaecology (ebe nafu maka umunwanyi, ma obu ihe gbasara

umunwanyi). Isi okwu nke ihe omumu a bu ichoputa maka nkechi eriri otubo umuaka amuru

ohuru (nozuru onwa itolu na afo ), ma onware mmetuta na odidi obara ha n’ime Federal

Medical Centre, Abeokuta.

Eweghi iwu jigidere oge kacha mma iji kechie eriri otubo. Otutu ihe omumu egosi la

na ichere nwamgbe oge tupu ekechie eriri otubo ga enyere nwata ahu aka n’ibuli onodu iron

ya kachakwa n’ime obodo n’emepeghi emepe di ka nke anyi ebe obara diala n’ihi okiko iron

zuru onu.

Oburu na ichoro isoro na ihe omumua, aga aju gi ufodi ajuju tinyere na aga eweputa

ufodu ihe gbasara gi idetu ya na ime data sheet mu.

Oburu na igafee iwu kwagidere isonye na ihe omumua, a ga etinye gi n’ otu ime

grupu abua. “Ogbugbu oge na njide eriri otubo” (mgbochi) grupu, ma obu “Nkechi n’oge nke

eriri otubo” (Nlereanya) grupu. Oburu na idabara n’ime mgbochi grupu, mgbe imuputara

nwa, ogbugbu oge nkeji abua ka aga egbu tupu, ekechie eriri otubo ya. Ma oburu na idaba na

“Nlereanya” grupu, aga ekechi eriri otubo nwagi osiso amuputara ya tupu sekondu iri agaefee

bu ka esi eme bu ya na ulo ogwu anyi a.

Ihe nile gbasara gi ga ano na nzuzo otu iwu si we kwuo, aha eji mara gi ga bu kwa ihe

ezoro ezo n’ime ihe odide mgbasa ozi.

Nkwenye gi na ihe omumua ga esi n’obi gi puta, tinyere na iga apu mgbe obula ichoro

ipu. Ma odaputa na ipuru, ogaghi egbochi anyi inyegi uru nile na nlekota nile kwesiri gi.

Oburu na icho nkowa ihe ndi ozo, kpoo onye isi omumu a Dokita Awolaja Babatunde

Stephen na akara igwe 08032911203.

Imee la.

48

Investigator’s Statement

I have provided an explanation of the above research program. The participant was

given an opportunity to discuss the study. A copy of the consent form has been given to the

participant for attestation.

_______________________ ___________________

Signature of Investigation Date

Participant’s Statement

Mu……………………………………………………….. kwenyere na mu aguola ma

gughari-kwaa ihe no na ihe omumua, ma ghota kwa otu ihe omumumu a di. Ajuolam ajuju

ma natakwa oziza n’ile banyere ihe omumua. Eweputalam onwem site na ime obim isoro na

ihe omumua. Aghotaram na mu ga akwusi ihe omumua oge obula omasirimu. Aghotaram na

mu nwere ike iju ajuju ndi ozo oge obula. Enwere mu oghere mkpachapu anya itule formu

nkwekolita ma juokwa ajuju banyere ya.

_____________________ ___________________

Signature/Left Thumb Date

Print of participant

_____________________ ____________________

Signature of Translator Date

(Where the patient does not speak English, to be done by someone that speaks the same

language as the patient)

____________________ __________________

Signature of Witness Date

49

APPENDIX II

RECRUITMENT DATA SHEET

OUTCOME OF DELAYED CORD CLAMPING IN TERM NEONATES AT THE

FEDERAL MEDICAL CENTRE, ABEOKUTA.

DATA SHEET I

SERIAL NUMBER................... HOSPITAL NUMBER...............

RANDOMIZATION NUMBER........... PHONE NUMBER................

NAME..................................................................................

AGE...........................................................................................

ADDRESS....................................................................................

LEVEL OF EDUCATION: [1] None [2] Primary [3] Secondary [4] NCE [5] ND [6] HND

[7] BSc [8] Postgraduate

OCCUPATION....................................................................

HUSBAND’S OCCUPATION............................................

RELIGION: 1. Christianity 2. Islam 3. Others, specify..................

PARITY.............................. NO OF LIVING CHILDREN.......................

LMP...................... EDD.............................

ESTIMATED GESTATIONAL AGE...............................(WKS)

BOOKING STATUS..............................................................

IF BOOKED, NO OF ANC VISITS..........................

DATE OF LAST ANC VISIT.......................

IS THE PATIENT ON IRON SUPPLEMENT: 1. YES 2. NO

DID SHE RECEIVE ANY ANTIMALARIAL DRUG? 1. YES 2. NO

BLOOD GROUP............................ GENOTYPE......................

DATE OF RECRUITMENT................................

TIME OF RECRUITMENT..................................

WEIGHT AT BOOKING....................................(Kg)

HEIGHT AT BOOKING....................................(m)

50

APPENDIX III

RECRUITMENT DATA SHEET

OUTCOME OF DELAYED CORD CLAMPING IN TERM NEONATES AT THE

FEDERAL MEDICAL CENTRE, ABEOKUTA.

DATA SHEET II

SERIAL NUMBER................... HOSPITAL NUMBER...............

RANDOMIZATION NUMBER........... PHONE NUMBER................

INFORMATION ON LABOUR

DATE AND TIME OF ONSET OF LABOUR.....................................

TYPE OF LABOUR: 1. SPONTANEOUS, 2.AUGMENTED, 3. INDUCED

DATE AND TIME OF DELIVERY.......................................

WAS EPISIOTOMY GIVEN? 1. YES 2. NO

ANY COMPLICATION OF THIRD STAGE ? 1. YES 2.NO

IF YES, WHICH ONE? 1. ATONY,

2. RETAINED PLACENTA

3.CERVICAL/PERINEAL LACERATION,

4. OTHERS SPECIFY............

EBL............................... (mL)

WAS OXYTOCICS GIVEN? 1. YES 2. NO

IF YES, 1. OXYTOCIN 2.MISOPROSTOL 3. ERGOMETRINE 4.OTHERS,

SPECIFY.............

WAS THERE POST RANDOMIZATION EXCLUSION? 1. YES 2.NO

IF YES, WHY? 1.Birth asphyxia 2. Instrumental delivery 3. Needed immediate

resuscitation 4. EMCS 5.Others, specify........................

PREPARTUM HAEMATOCRIT....................%

POSTPARTUM HAEMATOCRIT..................%

51

APPENDIX IV

RECRUITMENT DATA SHEET

OUTCOME OF DELAYED CORD CLAMPING IN TERM NEONATES AT THE

FEDERAL MEDICAL CENTRE, ABEOKUTA.

DATA SHEET III

SERIAL NUMBER................... HOSPITAL NUMBER...............

RANDOMIZATION NUMBER........... PHONE NUMBER................

INFORMATION ABOUT THE BABY

ESTIMATED GESTATIONAL AGE......................... (WKS)

DATE OF BIRTH.................................. TIME OF BIRTH...........................

SEX: 1.= MALE 2 = FEMALE

WEIGHT........................ (kgs) LENGTH............... (cm)

DID THE BABY CRY IMMEDIATELY AFTER BIRTH? 1.YES 2.NO

DID THE BABY REQUIRE RESUSCITATION? 1. YES 2.NO

APGAR SCORES AT 1 MINUTE.................., AT 5 MINUTES..............

DID THE BABY HAVE ANY CONGENITAL MALFORMATION? 1. YES 2.NO

WAS THE BABY BREASTFED AFTER DELIVERY? 1.YES 2. NO

HAEMATOCRIT AT 24 HOURS..................%

SERUM BILIRUBIN LEVEL AT 24 HOURS.......................mg/dL

RESPIRATORY RATE AT 24 HOURS.................../minute

DID THE BABY DEVELOP JAUNDICE BEFORE DISCHARGE 1. YES 2.NO

IF YES, WAS SERUM BILIRUBIN LEVEL DONE? 1. YES 2.NO

IF YES, SERUM BILIRUBIN LEVEL.........................mg/dL

DID THE BABY REQUIRE NICU ADMISSION FOR JAUNDICE/OTHER REASONS?

1. YES 2. NO

DID THE BABY REQUIRE PHOTOTHERAPY? 1. YES 2. NO

IF YES, HOW MANY TIMES...................

DID THE BABY REQUIRE EXCHANGE TRANSFUSION? 1. YES 2.NO

DATE OF DISCHARGE.......................................

52

APPENDIX V

RECRUITMENT DATA SHEET

OUTCOME OF DELAYED CORD CLAMPING IN TERM NEONATES AT THE

FEDERAL MEDICAL CENTRE, ABEOKUTA.

DATA SHEET IV

SERIAL NUMBER................... HOSPITAL NUMBER...............

RANDOMIZATION NUMBER........... PHONE NUMBER................

INFORMATION ABOUT THE BABY AT 6 WEEKS

WEIGHT..................(kg)

LENGTH..................(cm)

HAS THE BABY BEEN EXCLUSIVELY BREAST FED? 1.YES 2. NO

DID THE BABY RECEIVE IRON SUPPLEMENT? 1.YES 2. NO

ANY ILLNESS IN THE LAST 6 WEEKS? 1.YES 2. NO

IF YES, SPECIFY.........................

HAEMATOCRIT....................%

WAS THERE POST- RANDOMIZATION EXCLUSION? 1.YES 2. NO

IF YES, WHY?................

53

APPENDIX VI

WORK PLAN

Activity MAR

2014

APRIL

2014

MAY

2014

DEC

2014

JAN

2015

APRIL

2015

MAY

2015

JUNE

2015

JULY

2015

AUG

2015

Proposal writing XX XX

Ethical clearance XX

Submission of

proposal to college

XX XX

Pilot study XX

Data collection XX XX XX XX XX

Data

analysis

NOV

2015

Review of draft by

supervisor

DEC

2015

Final write up DEC

2015

Submission of

work to college

JAN

2016

54

APPENDIX VII

55

APPENDIX VIII

56

APPENDIX IX