Jurnal - Elective Caesarean Section

8/12/2019 Jurnal - Elective Caesarean Section

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Elective caesarean section

at 38 weeks versus 39 weeks:neonatal and maternal outcomesin a randomised controlled trial

Glavind, SF Kindberg, N Uldbjerg, M Khalil, AM Mller, BB

Mortensen,d OB Rasmussen, JT Christensen, JS Jrgensen, TB

Henriksen


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Introduction

British and American societies in obstetrics recommendelective caesarean section to be scheduled after 39 completedweeks of gestation.

This recommendation is based on a subset of severalobservational studies suggesting a strong associationbetween earlier gestational age at elective caesarean sectiondelivery and risk of respiratory morbidity that showed adecreasing incidence of the composite outcome withincreasing gestational age from 37 to 39 completed weeks of

gestation


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Introduction

In contrast, any maternal benefit of postponing electivecaesarean section to 39 completed weeks has not beenshown, but knowledge is sparse when it comes to maternalconsequences of elective caesarean section timing.

Confounding by indication may impair results fromobservational studies. In this case, neonates with a higherrisk of an adverse outcome may be over-represented incaesarean sections undertaken before 39 weeks for reasonsother than the caesarean section per se.

This methodological problem would only be solved in arandomised controlled trial.


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Objective

The purpose of this study was to investigate whetherelective caesarean section before 39 completed weeksof gestation increases the risk of adverse neonatal ormaternal outcomes


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Methods

DesignRandomised controlled multicentre open-label trial.

Setting

Seven Danish tertiary hospitals from March 2009 to

June 2011.

Population

Women with uncomplicated pregnancies, a singlefetus, and a date of delivery estimated by ultrasound

scheduled for delivery by elective caesarean section


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Result

Among women scheduled for elective caesarean section at38+3 weeks 88/635 neonates (13.9%) were admitted tothe NICU, whereas in the 39+3 weeks group 76/637neonates (11.9%) were admitted (relative risk [RR] 0.86,95% confidence interval [95% CI] 0.651.15).

Neonatal treatment with continuous oxygen for more than 1day (RR 0.31; 95% CI 0.100.94) and maternal bleeding ofmore than 500 ml (RR 0.79; 95% CI 0.630.99) were lessfrequent in the 39 weeks group, but these findings were

insignificant after adjustment for multiple comparisons. The risk of adverse neonatal or maternal outcomes, or a

maternal composite outcome (RR 1.1; 95% CI 0.791.53)was similar in the two intervention groups.


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Discussion

In this randomised controlled trial including 1274pregnant women, scheduling elective caesarean sectionat 39+3 weeks compared with 38+3 weeks did not resultin a significant decrease in neonatal admission within 2

days of birth. In addition, no secondary neonatal or maternal outcomes

improved significantly with late scheduling


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Discussion

Strengths of the study The randomised design

The data presented reflect the whole spectrum ofconsequences of timing of elective caesarean from

booking of the procedure to birth of the child The trial population was homogeneous

100% short-term follow-up rate

Date validated by ultrasound in 99.8% of the participant


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Discussion

Limitations of the study In terms of serious events such as stillbirth,

hysterectomy, thrombo embolism, or death, the studywas not powered to evaluate the influence of elective

caesarean section timing. The outcomes evaluated were all short-term

Delivery at 38 weeks may lead to increased healthcareuse in early childhood or increased risk of special

educational school needs compared with delivery at 39weeks of gestation, but this association has not beeninvestigated in elective deliveries only


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Discussion

Before applying the results to other populations and settings,several factors have to be considered.

Overall, the study population had a low body mass index andwas very homogeneous, and the study aimed to only includehealthy women with no a priori risks related to the neonate.

In addition, the eligible non-participating women may havehad a lower risk of an adverse neonatal outcome, becausethey were probably booked closer to their due date (morebreech presentations) and fewer women were to have repeat

procedures


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Discussion

The NICU admission rate was quite high compared with thoseof other studies. This may be a consequence of all neonataladmissions being included, whereas studies conducted infacilities with differentiated levels of neonatal care may haveexcluded neonatal admissions that were not to the NICU.

In terms of maternal morbidity, the most interesting aspectbefore the trial was whether more women with spontaneousonset of labour in the late ECS group would result in anincrease in the number of women with infection or

intraoperative complications because of the urgency of theprocedure


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Conclusion

This study found no significant reduction inneonatal admission rate after ECS scheduled

at 39 weeks compared with 38 weeks of

gestation


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Critical Appraisal


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4048 women with uncomplicated pregnancies, asingle fetus, and a date of delivery estimated byultrasound scheduled for delivery by electivecaesarean section

POPULATION

No interventionINTERVENTION

Group of women with elective CS at 38+3weeks vs women with elective CS at 39+3weeks

COMPARISON

NICU admission within 48 hours of birth, neonataldepression, NICU admission within 7 days, NICUlength of stay, neonatal treatment, and maternalsurgical or postpartum adverse events

OUTCOME


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Are the aims clearly stated? Yes. To investigate whether elective caesarean section

before 39 completed weeks of gestation increases the riskof adverse neonatal or maternal outcomes


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Are the statistical methods described? In the outcome analyses, relative risks and absolute risk

differences with 95% confidence intervals (95% CI) werecalculated for dichotomous outcomes using Fishers exacttest.

Non-Gaussian continuous variables were compared usingthe Wilcoxon rank-sum test, and birthweight wascompared using Students t test.

For the primary outcome and the maternal compositeoutcome a potential centre effect was evaluated by testing

the hypothesis of no treatment by centre interaction in amultiple logistic regression model.

Adjustment for multiple comparisons (Bonferroni) wasmade in evaluating the secondary outcomes


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Where are the biases? This study used homogenous sample, all the

characteristics variable not significantly differ betweentwo group. It also used strict sample selection, almost

perfect follow-up and standardized measurement.Hence, lack of bias found here.


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How do the results compare with previousreports? Rosenstein et al found a similar risk of fetal and neonatal

death associated with delivery and expectant managementat 38 weeks, whereas at 39 weeks, delivery carried a lower

risk of neonatal death than expectant management.

Comparing the incidence of a composite adverse neonataloutcome after caesarean delivery at 38 and 39 weeks ofgestation, Tita et al found an odds ratio of 0.67 and Wilmink

et al found an odds ratio of 0.71 in favour of delivery at 39weeks of gestation, which are both estimates that lie withinour calculated 95% CI of 0.651.15.


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What implications does the study have for

your practice? Study results could suggest that scheduling elective

caesarean section after the prevailing cut-off at 39+0weeks of gestation may have less impact on short-term

neonatal morbidity than previously anticipated. In themothers, timing of elective caesarean section at 38 or 39weeks seems to carry a similar risk of adverse events.

Accordingly, scheduling of elective caesarean section 35

days before 39+0 completed weeks may be an acceptableoption in women in whom an acute caesarean sectiondelivery should be avoided. Scheduling after 39 completedweeks may continue to be the best option


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Thank You

Jurnal - Elective Caesarean Section

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