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Immediate start of hormonal contraceptives for contraception

RHL Commentary by Culwell K

1. INTRODUCTION

"Immediate start" of contraceptives refers to starting the use of a contraceptive method immediately from the time of visit to a clinic, regardless of where the woman is in her menstrual cycle. This issue is of particular relevance to under-resourced settings as many providers in developing countries do not provide contraceptives to women who are not currently menstruating. Studies conducted in Cameroon, Ghana, Jamaica, Kenya and Senegal suggest that between 41% and 92% of non-menstruating family planning clients are denied contraceptive methods (1, 2). Also, in many cases, providers do not even feel comfortable providing contraceptive pills in advance for a woman to take home and start taking the pill at the time of her next menses (3). This creates a barrier to accessibility of contraceptives for women in under-resourced settings, where costs, lack of transportation, and child care can limit a woman's ability to return to the clinic. With immediate start, it is likely that more women would be able to initiate use of a modern contraceptive method successfully. This review sought to evaluate whether there are any differences in effectiveness, method continuation and acceptability of hormonal contraception when used under two different regimens, immediate-start or start at menstruation.

2. METHODS

The review authors employed a sound search strategy to identify appropriate randomized controlled trials. The search itself was thorough with adequate assessment of the quality of the studies and clear presentation of results. As stated in the review, meta-analysis could not be performed owing to differences in the interventions.

Immediate start of hormonal contraception as defined in this review also includes the instruction to use a back-up method of contraception (such as condoms) for the first 7 days.

3. RESULTS

This review (4) analysed data from five randomized controlled trials involving a total of 2427 women initiating different methods of hormonal contraception on different days of their menstrual cycle. Four trials compared "conventional start" (i.e. start of a contraceptive method coinciding with the next menses) with "immediate start" (5–8). One trial compared immediate start of a combined oral contraceptive (COC) with immediate start of the combined vaginal ring (9, 10). The primary outcomes evaluated in this review included contraceptive effectiveness, continuation rates, bleeding patterns, acceptability, and side-effects. The hormonal methods examined in these trials included various COCs, the injectable contraceptive depot-medroxyprogesterone acetate (DMPA), the combined transdermal patch, and the combined vaginal ring. Most of the participants in these trials were young women or adolescents. Two studies included women less than 18 years of age and only one study included women older than 35 years of age. All the trials were conducted in the USA.

None of the studies included in the review had sufficient statistical power to detect differences in contraceptive effectiveness. In one trial involving women aged 14–26 years, a statistically significant difference in contraceptive effectiveness was found between an immediate-start group that received DMPA and those in a "bridge" group that received a one-month supply of COCs, combined vaginal ring, or combined transdermal patch (as per choice of the study participant) for use until they returned for DMPA injection at their next menses (6). Women in the immediate-start DMPA group were significantly less likely to become pregnant than those in the bridge group [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.16–0.84] during the study period of six months. However, it is important to note that only 55% of women in the bridge group received their first DMPA injection. No differences in pregnancy rates were noted between groups in any of the other studies.

Method adherence or continuation is a theoretical benefit of the immediate-start approach. However, contraceptive method discontinuation rates were not significantly different between groups in any of the studies included in the review.

Bleeding patterns also did not differ between groups in any of the trials comparing conventional start to immediate start of the same method. In the trial comparing immediate start of COCs with immediate start of the combined vaginal ring (10), significantly fewer women in the ring group experienced prolonged bleeding (defined as bleeding or spotting episode lasting for 10 days) compared with the COC group (OR 0.42; 95% CI 0.20–0.89). Although it was not statistically significant, frequent bleeding (more than four episodes of bleeding or spotting) was also less likely to occur in the ring group (OR 0.23; 95% CI 0.05–1.03).

In the three trials that examined patient satisfaction, two found significant differences between groups. In the trial of immediate-start DMPA versus the bridge group, women in the immediate-start group were more likely to be very satisfied with their method at six months compared with those in the bridge group (OR 1.99; 95% CI 1.05–3.77) (6). In the trial comparing immediate-start COCs versus the combined vaginal ring, more women in the ring group reported being very satisfied compared with the COC group (OR 2.51; 95% CI 1.32–4.77) and more women in the ring group planned to continue using the method after the study period of three cycles (OR 2.51; 95% CI 1.32–4.77) (9).

4. DISCUSSION

4.1 APPLICABILITY OF THE RESULTS

In nearly all of the included trials, routine urine pregnancy tests were used at the time of the visit to the clinic, prior to immediate start of the contraceptive method and/or repeat pregnancy tests were administered after the first cycle of immediate start of a contraceptive. These tests may not be readily available in under-resourced settings and their routine use in these situations could be cost-prohibitive (see section 4.2).

Even though all studies included in this review were from the USA, there is no reason to believe that the findings of the review would not be applicable to under-resourced settings. Preliminary data from an ongoing randomized controlled trial in Nicaragua (11) support this notion.

Two of the five studies included in the review presented information on immediate start of the combined vaginal ring or the combined transdermal patch – two methods that are not usually available in under-resourced settings. Most applicable in these settings are the data obtained from three trials comparing immediate start to conventional start of COCs and DMPA.

4.2 IMPLEMENTATION OF THE INTERVENTION

Current evidence-based guidance from WHO is consistent with the findings of this review (12). Specifically, the WHO recommendations state that women can start all hormonal contraceptives at any time during their menstrual cycle (or at any time if the woman is amenorrhoeic) if it is reasonably certain that she is not pregnant. For settings where pregnancy tests are not readily available, the WHO guideline (12) includes a checklist on how to be reasonably sure that a woman is not pregnant based on clinical symptoms and sexual, menstrual, and reproductive history. In addition, emergency contraception can be given prior to immediate start of a method, to protect against pregnancy from acts of unprotected intercourse within the previous five days.

In order to proceed with immediate start of hormonal contraceptives, women should be counselled to use a back-up method of contraception (such as condoms) or to abstain from sex for the first 7 days after initiation of the method (or 2 days in the case of progestogen-only pills) to protect against pregnancy until contraceptive effect is achieved. There are settings in which this would be less feasible for women who have little power to negotiate condom use or abstinence with their partners. If a woman in this situation is counselled to wait until her next menses to start a method, there is a risk that the woman could become pregnant before starting such a method, or may not start a method at all. Existing clinic protocols may need to be changed to recommend immediate start of hormonal contraceptives. In addition, extensive education and training would be needed in many settings to re-train providers away from requiring clients return to the clinic at the time of their next menses to obtain contraceptives. Maintaining adequate supplies of contraceptives and an adequate method mix is crucial to implementation of immediate start of contraceptives.

The primary care setting would be the most likely site of implementation of immediate start of hormonal contraceptives. Many women receiving contraceptives at the secondary care level would likely be immediately postpartum. Initiation of contraceptives postpartum before a woman leaves the hospital is a different situation than immediate start of contraceptives for a non-postpartum woman. While most combined hormonal contraceptives are not recommended for immediate postpartum use, progestogen-only methods may be initiated immediately postpartum, particularly in non-breastfeeding women (13). Prescription of contraceptives for women with medical conditions, particularly methods classified by condition in Category 3 in WHO's Medical eligibility criteria for contraceptive use (13), may be provided at the secondary level of care.

There is strong and continued interest in providing contraceptives through community-based workers. Checklists developed by Family Health International for use by family planning providers, including community-based workers, contain questions to help providers to be reasonably sure that the woman is not pregnant prior to initiation of combined oral contraceptives or the injectable DMPA (14).

4.3 IMPLICATIONS FOR RESEARCH

Additional research in under-resourced settings is needed on immediate start of contraceptives, especially in settings where routine urine pregnancy tests are not available. Further research is also needed on the perspectives of users and providers on acceptability of, and satisfaction with, immediate start of contraceptives versus conventional start. Also, as stated in the review, further trials should be sufficiently powered to detect differences in pregnancy rates with the two options.

References

• Stanback J, Thompson A, Hardee K, Janowitz B. Menstruation requirements: a significant barrier to contraceptive access in developing countries. Studies in Family Planning 1997;28:245-50.
• Stanback J, Nutley T, Gitonga J, Qureshi Z. Menstruation requirements as a barrier to contraceptive access in Kenya. Eastern African Medical Journal 1999;76:124-6.
• Stanback J, Janowitz B. Provider resistance to advance provision of oral contraceptives in Africa. Journal of Family Planning and Reproductive Health Care 2003;29:35-6.
• Lopez LM, Newmann SJ, Grimes DA, Nanda K, Schulz KF. Immediate start of hormonal contraceptives for contraception. Cochrane Database of Systematic Reviews 2008;Issue 2. Art. No.: CD006260. DOI: 10.1002/14651858.CD006260.pub2.
• Murthy AS, Creinin MD, Harwood B, Schreiber CA. Same-day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods. Contraception 2005;72:333-6.
• Rickert VI, Tiezzi L, Lipshutz J, Leon J, Vaughan RD, Westhoff C. Depo now: preventing unintended pregnancies among adolescents and young adults. Journal of Adolescent Health 2007;40:22-8.
• Westhoff C, Morroni C, Kerns J, Murphy PA. Bleeding patterns after immediate vs. conventional oral contraceptive initiation: a randomized, controlled trial. Fertility and Sterility 2003;79:322-9.
• Westhoff C, Heartwell S, Edwards S, Zieman M, Cushman L, Robilotto C, et al. Initiation of oral contraceptives using a quick start compared with a conventional start: a randomized controlled trial. Obstetrics and Gynecology 2007;109:1270-6.
• Schafer JE, Osborne LM, Davis AR, Westhoff C. Acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive. Contraception 2006;73:488-92.
• Westhoff C, Osborne LM, Schafer JE, Morroni C. Bleeding patterns after immediate initiation of an oral compared with a vaginal hormonal contraceptive. Obstetrics and Gynecology 2005;106:89-96.
• Nanda K, Stanback J, Rountree RW, Cameron SB. Randomized trial of "Quick Start" versus advance provision of oral contraceptive pills in Nicaragua (abstract). Obstetrics and Gynecology 2008;107:50S.
• Selected practice recommendations for contraceptive use. Second edition. Geneva: World Health Organization; 2005.
• Medical eligibility criteria for contraceptive use. Third edition. Geneva: World Health Organization; 2004.
• Screening checklists for family planning services. Tools for service providers Research Triangle Park, NC: Family Health International; 2008. Available at: http://www.fhi.org/en/RH/Pubs/servdelivery/checklists/index.htm. Accessed 1 December, 2008.

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This document should be cited as: Culwell K. Immediate start of hormonal contraceptives for contraception: RHL commentary (last revised: 2 February 2009). The WHO Reproductive Health Library; Geneva: World Health Organization.

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