Issues in

Contraception:

Worth Talking

AboutDr Nurulhuda Samsudin

What’s worth talking about?

• Everything.

What’s worth talking about in < 45 minutes?

The contraception “quick user manual”

• Getting started

- Making the right contraception choice.

• Troubleshooting

- Missed pills

- Delayed injectables

• Help

- Emergency contraceptions

Getting Started- What affect the couple’s

choice?

The contraceptive dilemma:

Maximum safety Maximum effectiveness

Less effectiveness Less safety

Examples in order of ‘safety’

Coitus interuptus

Fertility awareness

Examples in order of efficacy

Injectable/Implants

IUCD

Pills

Getting Started- Reproductive Decision- The Factor Wheel

Reproductive Decisions

Use of Contraception

Society

Culture

Religion

StatusAbortion laws

Personal attitude

Availability

Contraception methods

Service availability

Personnel

Children and their

valueIndividual

identity

Career

Self esteem

Unconscious factor

Couple relationship

Expectations

Family/Parents

Friends

Peer group

Class

Education

Knowledge

Beliefs

Myth

Getting Started- Knowing your patientThe 7 contraceptive ages

Age

0 Birth to puberty Sex and reproductive health education

1 Puberty to marriage(or equivalent) Pills, Injectables/Implants (WHO 2)

+ Condoms – protection against STD

* Emergency contraception

2 Marriage to equivalent to 1st child Any methods

Followed by fertility awareness

3 During breastfeeding LAM, POP, barrier

IUCD, Injectables, implants (LARC)– for

long spacing.

4 After breastfeeding Continue with ‘age 3’ method.

Shift to COCP or LARC

5 After the (probable) last child LARC, Pills, Barrier

6 Family complete IUCD/ male or female sterilisation

7 Perimenopausal (no sterilisation) IUCD

Trouble Shooting

Barrier method

Coitus interruptus

Calendar method

IUCD

Emergency Contraception

Missed pills

Delayed injectables

Precautionary & corrective

steps

+/-Emergency

contraception

Missed Pill-

COCP/CHC

Missed Pills- COCP/CHC

• Getting to concept right- The Horse Shoe

The Pill Free Period

The Scientific Advice for Missed Pills- Shut the door and

keep it shut!

• 7 consecutive pills are enough to put the ovaries to sleep- Shutting the door.

• Thereafter, 8-21 pills are simply to maintain the ovaries in quiescence- keeping the door shut.

• More than 7 pills missed in total risks ovulation. Remember horse shoe.

2 Unresolved

Issues…even experts

disagree

• What constitute “missed pill”?

• COCP containing 30-35mcg EE versus Ultra Low Dose

COCP containing 20mcg EE.

What Constitute Missed Pills- The Debate

Continues

• Missed pills- trigger for

the pill taker to take

specific action other than

continue pill taking.

• 2 determining factors:

- Time of cycle.

- Number of pills.

The objective of the WHO was to

provide an evidence-based yet simple and

harmonized guide for missed pill taking.

FFPRHC (2005) aides memoir for ‘missed pill rules’

• Just keep going.

• She should take a pill as soon as possible and then resume her usual pill-taking schedule.

• If the missed pills are in Week 3 she should omit the pill-free interval.

• A back-up method (usually condoms) or abstinence should be used for 7 days if the following numbers of pills are missed:

Two for twenty [i.e. if two or more 20 μg ethinylestradiol (EE) pills are missed]

Three for thirty (i.e. if three or more 30–35μg EE pills are missed]

Lightweight vs Featherweight

• COCP containing 30-35mcg EE versus Ultra Low Dose

COCP containing 20mcg EE.

• Evidence is limited on the pregnancy risk when missing

pills contain ≤20μg EE, but theoretically the pregnancy

risk may be higher.

• “Cautious approach is advised when missing these

COCs.”- FFPRHC Guidance (July 2006)

WHOSPR & FFPRHC (2005) Guidelines-The Critism

• Many women are unsure of the dose of ethinylestradiol in their pill, having two rules, one for 30–35mcg pills and one for 20mcg pills, would lead to confusion. “One rule for all” would be better.

• There is no universally accepted definition of a “missed pill.” There is no definition in the recommendations.

? Extending the dose regimen to more than 36 h (taking a contraceptive pill more than 12 h late from the designated daily time).

? Being 2 days late starting the contraceptive pill after a pill-free interval might mean between 49 h and 71 h late.

Extra hormone-free hour matters.

• There is no strong evidence that it is safe to miss up to three 30–35mg pills at the start of a new pack without using back-up contraception or EC.

Ovulation after deliberate extension of the pill-free interval has been documented and is linked to the type and dose of steroids used, the administration regimen, users' adherence, and the individual responsiveness of women taking the combined oral contraceptive pill

The small studies done to detect ovulation after deliberate extension of the HFI were not powered to detect wide inter-individual variability.

Mansour & Fraser;The Lancet, Volume 365, Issue 9472, Pages

1670 - 1671, 14 May 2005

Similiarly….

• “ In my view it is very unfortunate that the latest

(2005)WHOSPR – on which Faculty (UKMEC) and fpa

leaflet advice is based- issued instruction ( against my advice)

which differ according to the estrogen dose in particular pill.

I argue this is illogical, given that individual variation in blood

levels and response to contraceptive hormones is so great.

Even with the 30-53mcg brands, ovulation has been

demonstrated occasionally if the PFI is lengthened to only 8

or 9 days”

[Guillebaud J 2005 Journal of Family Planning and Reproductive Health Care

31:252]

The Response..

• The scientific evidence base of WHOSPR has not changed significantly since 2005.

• Anecdotal evidence suggests that women and health professionals found the 2005 rules complicated and difficult to use.

• The rules were not universally adopted and the pharmaceutical industry continued to give patient information advising the original missed pill rules in patient information leaflets, which suggested reduced efficacy after a pill was 12 hours late.

• The UK Medicines and Healthcare products Regulatory Agency (MHRA) identified a need for clearer, more consistent rules and issued new missed pill guidance in 2011, which has been approved by the FSRH.

FSRH Guidance (October 2011)

Combined Hormonal Contraception

Missed Pills- POP

Understanding POP

• All POP alter cervical mucus to

prevent sperm penetration.

• Traditional POP prevents

ovulation but the effect are

variables.

• Desogestrel only pill

(Cerazette) results in

anovulatory cycles in 97% of

users.

Missed POP- Indication for EC

• This decision should be based on the mucus effect.

• Emergency contraception (EC) should be offered for any unprotected intercourse that occurred:

After the 3-h delay (more than 27 h since the last pill) which might lead to loss of the mucus effect, but before two pills have been taken to restore it.

• A minimum 2 days of extra precautions should then follow.

• For Cerazette, if unprotected sex occurs more than 36 h since the last pill, EC should be offered, followed by 2 days of extra precautions.

Progesterone Only Injectables- Delayed

Injections and The Controversies

• What is the time frame for delayed injection for minimal risk of ovulation?

• Using anovulants models, the risk of conception is low up to 7 days delayed injection.

• Most international guidelines e.g FSRH, CDC gives 2 weeks leeway.

• “DMPA can be given up to 4 weeks late without requiring additional contraceptive protection. For NET-EN, the repeat injection can be given up to 2 weeks late without requiring additional contraceptive protection.”

WHO SPPR 2008

Response to the WHOSPR recommendation by CDC 2013

• A systematic review identified 12 studies evaluating time to pregnancy or ovulation after the last injection of DMPA.

Pregnancy rates were low during the 2-week interval following the reinjection date.

For 4 weeks following the reinjection date, data were sparse and one study included a large proportion of breastfeeding women.

Paulen ME, Curtis KM. When can a woman have repeat progestogen-only injectables—depot medroxyprogesterone acetate or norethisterone enantate? Contraception 2009;80:391–408

• Studies also indicated a wide variation in time to ovulation after the last DMPA injection, with the majority ranging from 15 to 49 weeks from the last injection.

Delayed Injectables

FSRH guidelines 2008

Emergency Contraception- The important

role in reducing unintended pregnancies

• Emergency contraception can reduce the risk of unintended pregnancies.

• The number of unintended pregnancy is increasing.

Teenage pregnancies.

Poor contraception prevalance rate among older/married couple in Malaysia.

Rising rape cases.

The number of rape cases has risen from 1 760 in 2004 to 3 262 in 2009.4

Sex, Youth & Contraception

• A survey by The National Population and Family Development

Board revealed sexual intercourse among youth, age 13 to 24 years

old was reported at 1% in 1994 and has risen to about 2% in 2004.1

• Other study have reported the prevalence as high as 13%.

Sex, Youth &

Contraception- Serious

unmet need for

contraception

Contraception Prevalance Rate Among

Married Couple

• In Malaysia there is an increasing trend in the CPR between 1966 to 1994, then it plateau at about 50%.

• The recent figure in 2004 showed that only 51.7% of married Malaysian women are practicing family planning.

• The main reasons given:

Plan to conceive (39%),

Concerned of side effects (27%) and

Not permitted by the husbands (13%).

Prevention of Unintended Pregnancies-

Why it Matters

• Unwanted effects of teenage pregnancies:

High risk pregnancy.

Social problem e.g dropping out from school,unemployment etc.

Illegal abortion.

Baby dumping.

• Report on the Confidential Enquiries into Maternal Death (CEMD) Malaysia 2001 – 2005 which revealed that up to 70% of the maternal deaths never practiced any form of family planning.

Emergency Contraceptions

• Copper-bearing intrauterine device (Cu-IUD)

• Yuzpe regime

• Levonorgestrel (LNG)

• Ulipristal acetate (UPA)

Copper-bearing intrauterine device (Cu-IUD)

• Copper is toxic to the ovum and sperm.

• (Cu-IUD) is effective immediately after insertion and works primarily by inhibiting fertilisation.

• It has both pre & post fertilisation effect.

• Highly efficacious, failure rate < 1%

• There is also an anti-implantation effect.

A potential arbotificient.

Medico legal and ethical implication.

Thus, it should be inserted before implantation.

Mean time from ovulation to implantation is 9 (range 6–18) days

Should be fitted within the first 5 days (120 hours) following first UPSI in a cycle or within 5 days from the earliest estimated date of ovulation.

Case Illustration

• Regina v. Dhingra 24 January 1991, Mr Justice Wright

did not convict a GP accused of illegal abortion by

inserting IUCD 11 days after intercourse.

“ I further hold, in accordance with the uncontroverted

evidence that I have heard, that a pregnancy cannot come

into existence until the fertilized ovum has become

implanted in the womb, and that stage is not reached

until, at the earliest, the 20th day of a 28-day cycle and in

all probability, until the next period is missed.”

LNG – MECHANISM OF ACTION

• Levonorgestrel (LNG) works primarily by inhibition of ovulation.

• LNG taken prior to the luteinising hormone surge has been shown to result in ovulatory dysfunction in the subsequent 5 days.

• LNG can thus inhibit ovulation for 5–7 days, by which time any sperm in the reproductive tract will have become non-viable.

LNG 1.5mg LNG 0.75mg per tablet

LNG- How Effective?

Efficacy of LNG over time when compared with Day 1 administration

since UPSI.

Time since UPSI Odds Ratio 95% CI

Day 2 0.68 0.36–1.28

Day 3 1.74 0.94-3.14

Day 4 0.87 0.26-2.89

Day 5 5.81 2.87–11.76

Pregnancy rate when LNG taken within 24 hours – 0.4%

Licensed for use within 72 hours.

Piaggio G, Kapp N, von Hertzen H. Effect on pregnancy rates of the delay in administration of levonorgestrel for

emergency contraception: a combined analysis of four WHO trials. Contraception 2011; 84: 35–39

LNG- Side effects & Interactions

• Headache, nausea and altered bleeding patterns.

• If a woman vomits within 2 hours of taking LNG she should take a further dose as soon as possible or offer IUCD.

• If in doubt about whether menstruation has occurred, a pregnancy test should be performed ≥3 weeks after UPSI has occurred.

• Women on liver enzyme-inducing drugs or who have stopped using them (≤28 days ago) should be offered a Cu-IUD.

Yuzpe Regimen

Dr Al Yuzpe MD, FRCS

Yuzpe Method

• Devised in the mid 1970s.

• The original method consist of 2 tablet of COCP containing 250mcg LNG with 50mcg EE taken 12 hours apart.

• This has been supplanted by progesterone only EC.

• Also, the high dose COCP has been largely replaced by low dose COCP.

• Modified Yuzpe method;

e.g Micrgynon (30mcg EE, 15mcg LNG) 4 tablets taken 12 hours apart.

• Started within 72 hours of UPSI.

Yuzpe vs POEC

Relative risk of pregnancy for levonorgestrel compared with the Yuzpe

regimen was 0.36 (95% CI 0.18-0.70)

Lancet. 1998 Aug 8;352(9126):428-33.

Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral

contraceptives for emergency contraception. Task Force on Postovulatory Methods of Fertility

Regulation.

LNG Yuzpe Method

Pregnancy rate 1.1% 3.2%

Nausea 23% 50%

Vomitting 5.6% 18%

Ulipristal Acetate

• A progesterorne receptor modulator.

• Work by inhibition or delay of ovulation.

• Administered within 120 hours.

• No apparent decline in efficacy within that time period.

Fine P, Mathe H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48–120 hours after

intercourse for emergency contraception. Obstet Gynecol 2010; 115: 257–263

UA vs LNG

Assessment• Determine UPSI has taken within the time frame when EC is

effective.

• Determine risk of pre-existing pregnancy.

• Discuss broader issues:

STD

Sexual assault

• Determine contraindications.

• Explained side effects.

Followup

• Pregnancy test if normal menses does not resume 21 days after EC.

• Long term contraception.

Start after normal menses vs ‘Quick Start’

Quick Start

Ethico-legal issues

Outside term of product license.

Illegal to insert IUCD in a pregnant woman.

Because pregnancy cannot be excluded it is recommended when:

- The woman is likely to continue to be at risk of pregnancy.

- The woman has expressed a preference to begin contraception as soon as possible.

- POP, COCP, Implants, IUCD.

• Treatment of STI.

Checklist for Quick Start after EC

If risk of pregnancy cannot be reasonably excluded, the contraceptive provider should ensure that the woman is:

• Likely to continue to be at risk of pregnancy or that she has expressed a preference to begin contraception immediately.

• Aware that there is a possibility of pregnancy.

• Informed that there is a theoretical risk from fetal exposure to contraceptive hormones but most evidence indicates no harm.

• Aware that pregnancy cannot be excluded until she has had a pregnancy test no sooner than 3 weeks after the last episode of unprotected sexual intercourse.

• Provided with a pregnancy testing kit or informed of alternative options for pregnancy testing, including local providers of free testing.

• Given advice on additional contraceptive precautions.

• Offered a supply of condoms or informed of local providers of condoms.

• Advised to return if there are any concerns or problems with her contraception

CLEAR DETAILED DOCUMENTATION IS ESSENTIAL

Conclusion

• Get to know your patient.

• Conceptualize the various methods of contraception and

its mechanism of action.

• EC is not a substitute to appropriate contraception.

However due to the serious unmet need for contraception,

EC has played a bigger role in preventing unplanned

pregnancies.

Thank you