When used correctly and consistently, oral contraceptives (OCs) are among the most effective reversible methods of contraception. But reported pregnancy rates during the first year of OC use are as high as 32 percent.1 Because a major contributing factor to these OC "failures" is thought to be missed pills, researchers are trying to determine how women's daily routines, interpretations of pill taking, or knowledge about OCs affects their pill use. Such information is needed so that family planning programs can help clients take OCs more consistently.
One place where this issue has been explored is China. Family planning there is nearly universal among people of reproductive age, and OCs are free and widely available. Yet the pregnancy rate during the first year of OC use has been about 11 percent,2 much higher than that in many other countries. Investigators from the University of Michigan School of Nursing, Ann Arbor, Michigan, USA, and China's Hunan Family Planning Committee, Hunan Family Planning Institute, and Beijing University have sought to determine why this is so.3
Five urban and five rural women who were married and using No. 1, a Chinese brand of combined OCs containing 35 µg ethinyl estradiol and 600 µg norethindrone, were included in the study. All women were instructed to take one pill a day for 22 consecutive days. No placebo pills were available, and women were to resume pill taking on the fifth day of menses. For three cycles, women were given a special pill package with a computer inside that recorded the time and date that each pill was dispensed.
During in-depth personal interviews, each woman was asked to develop a detailed calendar showing unusual events that occurred during each of her cycles, including sickness, absence from home, overnight visitors, or other disruptions to home or work routines. Each woman was also shown the computer-recorded data on her pill use and asked to explain missed pills or extended pill-free intervals.
Computer-recorded data showed, notably, that no woman who remained in the study for all three cycles took all of her pills on the correct days. According to the World Health Organization, women may be at increased risk for pregnancy if they miss as few as two active pills in a row (depending on when in the cycle they miss them) or if they extend the pill-free interval beyond seven days.4 Four women missed at least two consecutive pills during the study; three of the same women also had an overly long pill-free interval. Although no pregnancies were reported, investigators considered three of the 10 women to have been at increased risk of pregnancy.
Analysis showed three main reasons for missed pills: changes in the routine of daily life, absence of husbands, and presence of bleeding. Interviews showed that the women sometimes confused spotting with menses and often did not take pills if they detected any bleeding at all. Data also showed that more rural than urban users took their pills consistently. The researchers hypothesized this occurred because rural users had more routine daily schedules.
On the basis of their data, the researchers suggested several yet-to-be evaluated strategies to improve consistency of OC use in China:
Educational materials could be created to stress the importance of consistent OC use even when a husband is temporarily not at home.
Pill-taking instructions could be changed so that women are told to take one active pill daily for 22 days and to resume taking active pills after six pill-free days, regardless of menstruation. This would create a more routine 28-day cycle and remove any link between pill taking and menses, so women would no longer have to interpret the meaning of bleeding.
Mention of menses could be removed from pill-taking instructions to further dispel the myth that pills cannot be taken on bleeding days.
Bangladesh provides another good opportunity to study pill-taking behaviors. Nearly half of all contraceptive users in Bangladesh take the pill,5 yet studies show that many Bangladeshi women do not follow correct pill-taking procedures.6 A recent study conducted by the University of New England in Australia, Ipas in North Carolina, USA, and the University of Dhaka in Bangladesh aimed to determine predictors of inconsistent OC use in rural Bangladesh.7
The study included 801 of some 1,400 OC users served by government family planning workers (FPWs) and surveyed between 1995 and 1996 about adherence to OC pill-taking regimens. Women in the study had been using 28-day pill packets containing 21 active pills and seven iron or placebo pills for at least six months.
Self-reports of past pill-taking behavior were recorded for each woman. A woman's pill taking was defined as inconsistent if she remembered missing one or more active pills during the last six months of OC use. Several factors — including religion, place of residence, access to television or radio, duration of OC use, side effects, knowledge about contraindications, and visits by a FPW during the last six months — were also analyzed as potential predictors of inconsistent use.
Half of the women reported missing at least one active pill during the last six months, but an even higher proportion may have used their OCs inconsistently. Research conducted by FHI in 1996 comparing self-reported data on pill-taking behavior with computer-recorded data (such as that used in the study from China) has shown that in self-reports many women underestimate the number of pills that they miss.8
Data also showed that four factors significantly increased a woman's risk of inconsistent OC use: lack of knowledge about contraindications to OC use, no visit by a FPW in the last six months, Islam as a religion, and no access to television or radio. Lack of knowledge about contraindications was the most significant predictor of inconsistent use. This finding suggests that, in general, "less-informed women may have a tendency to use the pills inconsistently, and that increased access to more comprehensive information could help to alleviate this trend," the researchers stated.
To increase consistent use of OCs in rural Bangladesh, the authors made the following recommendations, which — while not evaluated in Bangladesh or elsewhere — may be applicable to rural settings in other countries:
Regular in-service training about issues related to OC use should be offered to providers. All potential OC users should be counseled on the contraindications and possible side effects of OC use, as well as on how to use OCs correctly.
Regular contact is needed between service providers and clients in rural areas. The family planning program of Bangladesh recently switched from a home-delivery system to a fixed-site, clinic-based delivery system, which needs to be promoted to improve women's awareness, and use, of the clinics.
For social or religious reasons, some Muslim women have limited mobility within their communities, which may decrease their contact with service providers. Since many Muslim women do not leave the home without a male companion, involving men in women's reproductive health decisions — by counseling men as well as women — could facilitate adherence to OC regimens.
Behavior change communication materials need to be revised, and mass media programs could be adjusted, to include information on user behavior, such as instructions on how to take pills correctly and on what to do if pills are missed. Also, instructions should reinforce the importance of taking pills every day.
— Kerry L. Wright
References
Jejeebhoy S. Measuring contraceptive use-failure and continuation: an overview of new approaches. In Bogue DJ, Arriaga EE, Anderton DL, eds. Readings in Population Research Methodology. New York, NY: United Nations Fund for Population Activities, 1993; Fu H, Darroch JE, Haas T, et al. Contraceptive failure rates: new estimates from the 1995 National Survey of Family Growth. Fam Plann Perspect 1999;31(2):56-63.
Wang SX, Wing SG, Hang M. A study on the effects of common contraception measures in China. Popul Res 1991;29:1 [In Chinese].
Oakley D, Yu M-Y, Zhang Y-M, et al. Combining qualitative with quantitative approaches to study contraceptive pill use. J Women's Health 1999;8(2):249-57.
World Health Organization. Selected Practice Recommendations for Contraceptive Use. Geneva, Switzerland: World Health Organization, 2002.
National Institute of Population Research and Training, Mitra and Associates, and ORC Macro International Inc. Bangladesh Demographic and Health Survey 1999-2000. Dhaka, Bangladesh, and Calverton, MD: National Institute of Population Research and Training, Mitra and Associates, and ORC Macro International Inc., 2001.
Mitra SN, Lerman C, Islam S. Bangladesh Contraceptive Prevalence Survey, 1991Key Findings. Dhaka, Bangladesh: Mitra and Associates, 1992; Larson A, Islam S, Mitra SN. Pill Use in Bangladesh: Compliance, Continuation, and Unintentional Pregnancies. Report of the 1990 Pill Use Study. Dhaka, Bangladesh: Mitra and Associates, 1991.
Khan MA, Trottier DA, Islam MA. Inconsistent use of oral contraceptives in rural Bangladesh. Contraception 2002;65(6):429-33.
Potter L, Oakley D, de Leon-Wong E, et al. Measuring compliance among oral contraceptive users. Fam Plann Perspect 1996;28(4):154-58.
Starting oral contraceptives (OCs) while being supervised by a health care provider during the first clinic visit, regardless of the time in a woman's menstrual cycle — an initiation method called Quick Start — may improve OC continuation rates without increasing menstrual side effects.
OCs have traditionally been initiated during or shortly after menses, in part to make sure a woman is not pregnant when she starts taking her pills. However, waiting until menses to start OCs may not be successful if women lose motivation, are confused about when to start taking pills, or become pregnant while waiting for their menses. In fact, up to a quarter of women waiting to initiate OCs may never even take their first pill.1 "We thought that starting the pill while the patient was in the clinic asking for it might address all of these issues to some degree," says Dr. Carolyn Westhoff, a professor of obstetrics and gynecology at Columbia University in New York, USA, and one of the developers of the Quick Start approach.
One common objection to Quick Start is that a woman who starts her pills mid-cycle may be pregnant. But pregnancy can usually be ruled out using a simple urine pregnancy test. Where such tests are not available, a simple six-question checklist has been created by FHI (based on criteria developed by the U.S. Agency for International Development and the World Health Organization) to help providers be reasonably sure that a woman is not pregnant. The checklist is available in English, Spanish, and French. In addition, research has shown that OC use during early pregnancy does not harm a developing fetus.2
Cathryn Jirlds/FHI
A family planning provider helps a client begin use of oral contraceptives during a clinic visit — an initiation method that may improve continuation rates.
At family planning clinics in New York, Dr. Westhoff and colleagues recently evaluated three-month OC continuation rates among 227 Hispanic women, 58 of whom used Quick Start to initiate OC use and 169 who planned to initiate OCs at other times after they left the clinic.3 Taking all variables associated with continuation into account, women who took their first pill at the clinic were nearly three times more likely to start their second pack of pills than were women who planned to start their pills later.
Another Quick Start study was conducted by researchers at Case Western Reserve School of Medicine, Cleveland, Ohio, USA, and Allegheny General Hospital, Pittsburgh, Pennsylvania, USA, among nearly 200 women ages 22 and younger.4 Nearly three-quarters of Quick Start initiators, compared with just more than half of the young women who were instructed to initiate their pills on the first Sunday after their next menses, were still using OCs after three months. The study also showed no differences between groups in nausea, vomiting, or breakthrough bleeding up to one year after OC initiation. Dr. Westhoff and colleagues also conducted a randomized trial to specifically compare bleeding patterns of women using Quick Start with those of women using a traditional start, and they found no differences in the number of bleeding or spotting days or the duration of bleeding and spotting episodes between groups.5
Although these studies have all been conducted in the United States, Dr. Kavita Nanda, an associate medical director at FHI, reports that she and fellow researchers are evaluating potential sites for an upcoming study to examine continuation rates and bleeding patterns for women in the developing world who use Quick Start initiation versus traditional initiation using an advance-provision strategy.
Advance provision of OCs — providing nonmenstruating women with one or more packets of pills they can take home and initiate once menstruation has occurred — is the standard alternative to Quick Start. But even advance provision is not available in many countries. "Quick Start has great potential for the developing world," says Dr. John Stanback, an FHI senior associate who has studied advance provision of OCs in sub-Saharan Africa.6 "But we also need to make sure that providers know that advance provision is a safe alternative, for example, when pregnancy cannot be ruled out or for women who wish to wait until their next menses to begin pill taking."
— Kerry L. Wright
References
Oakley D, Sereika S, Bogue EL. Oral contraceptive use after an initial visit to a family planning clinic. Fam Plann Perspect 1991;23(4):150-54.
Bracken MB. Oral contraception and congenital malformations in offspring: a review and meta-analysis of prospective studies. Obstet Gynecol 1990;76(3 Pt 2):552-57.
Westhoff C, Kerns J, Morroni C, et al. Quick Start: a novel oral contraceptive initiation method. Contraception 2002;66(3):141-45.
Lara-Torre E, Schroeder B. Adolescent compliance and side effects with Quick Start initiation of oral contraceptive pills. Contraception 2002;66(2):81-85.
Westhoff C, Morroni C, Kerns J, et al. Bleeding patterns after immediate versus conventional contraceptive initiation: a randomized controlled trial. Fertil Steril 2003;79(2):322-29.
Stanback J, Janowitz B. Provider resistance to advance provision of oral contraceptives in Africa. J Fam Plann Reprod Health Care 2003;29(1):35-36.
In various developed countries, lack of a daily pill-taking routine and lack of client knowledge about correct oral contraceptive (OC) use contribute to nonadherence to pill-taking regimens, research has shown.
The findings suggest that providers can play an important role in increasing OC adherence by helping clients establish a daily pill-taking routine, understand the instructions for OC use, and identify where to obtain further OC information should a problem or question arise. The need to improve OC adherence is clear: It has been estimated that nonadherence to OC regimens contributes to 15 percent of the more than one million unplanned pregnancies occurring each year in the United States alone.1
To determine variables associated with lack of OC adherence, researchers from Health Decisions, Inc., and the University of North Carolina, Chapel Hill, North Carolina, USA, conducted a survey in urban Denmark, France, Italy, Portugal, and the United Kingdom among some 6,500 women who had ever used OCs.2 From 1995 to 1996, researchers from these institutions and Planned Parenthood Federation of America, New York, NY, USA, also delivered questionnaires (in part to identify characteristics affecting consistency of OC use) to nearly 1,000 U.S. women who were initiating OCs or switching from another method to OCs.3 In both studies, the strongest predictor of OC nonadherence was lack of a daily pill-taking routine: Those women who did not have an established routine were three to five times more likely to miss pills than were those who had such a routine. The studies also found that women who understood little or none of the written information that came with their OC packages were at least twice as likely to use their pills inconsistently as were those who completely understood the instructions. Other factors that predicted OC nonadherence (though not as strongly) included dissatisfaction with counseling about OCs and the presence of side effects such as hair growth, breast tenderness, nausea, and bleeding problems.
The researchers subsequently suggested several ways that providers can help improve OC adherence:4
Help each woman consider her contraceptive choices according to her individual needs and concerns.
Stress the importance of a daily routine for pill taking.
Emphasize that most OC side effects — especially spotting and bleeding — are transient.
Dispel OC misinformation, and discuss noncontraceptive health benefits of OCs.
Demonstrate correct use of the specific OC prescribed.
Provide easy-to-understand oral and written instructions about proper OC use and what to do in case pills are missed.
Suggest a backup contraceptive method (and provide a few condoms).
Tell clients how to obtain more information about OCs and their use, in case problems or questions arise.
Follow clients for signs of lack of adherence to pill-taking regimens. For example, telephone calls or visits from clients about spotting should alert providers to inconsistent OC use and may be an opportunity to review pill-taking instructions.
— Kerry L. Wright
References
Rosenberg MJ, Waugh MS, Long S. Unintended pregnancies and use, misuse and discontinuation of oral contraceptives. J Reprod Med 1995;40(5):355-60.
Rosenberg MJ, Waugh MS, Meehan TE. Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation. Contraception 1995;51(5):283-88.
Rosenberg MJ, Waugh MS, Burnhill MS. Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation. Fam Plann Perspect 1998;30(2):89-92.
Rosenberg M, Waugh MS. Causes and consequences of oral contraceptive noncompliance. Am J Obstet Gynecol 1999;180(2 Pt 2):276-79.
