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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.
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, 1991 Key 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.
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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 |
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A family planning provider helps a
client begin use of oral contraceptives during a clinic
visit — an initiation method that may improve
continuation rates.
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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.
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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.
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