- Email: [email protected]
Hormonal pregnancy test redux
Contraception 66 (2002) 295–296
Short communication
Hormonal pregnancy test redux John Stanback*, Elizabeth Raymond, Barbara Janowitz Family Health International, Research Triangle Park, NC 27709, USA Received 20 March 2002; received in revised form 2 May 2002; accepted 19 June 2002
Every day, health providers in many poor countries face a difficult choice when new clients request hormonal contraception. Providers have been trained that pregnancy must be excluded before hormonal methods are dispensed. However, in some clinics, up to half of new clients may be breast-feeding mothers with lactational amenorrhea. In the many areas where pregnancy tests are not routinely available, providers must either delay initiation of contraception until the client begins menstruating or rule out pregnancy by other means. Our previous research has shown that in many countries, providers often send post-partum women home without an effective method, putting them at risk of unintended and often dangerous pregnancies [1]. Excluding pregnancy by a history and exam is a good option [2] for the majority of new clients, including postpartum women who present for services within the first 6 months after delivery. But ruling out pregnancy is more difficult for women who present between 6 months postpartum and the onset of menses, sometimes a year or more post-partum, when fewer women remain abstinent and lactational infecundability can no longer be relied upon to exclude pregnancy. In a study we conducted in Kenya, providers were able to rule out pregnancy for 98% of clients who were within 6 months post-partum, but for only 46% of amenorrheic clients presenting more than 6 months after delivery. In fact, though, very few of the latter group (less than 3%) were actually pregnant. Given the large numbers of women affected, and the risks inherent in pregnancy and childbirth in the countries where they live, amenorrheic women presenting for contraception beyond 6 months post-partum need a new option. If pregnancy cannot be excluded by pregnancy test or by history (e.g., by determining that the woman has not had unprotected intercourse since delivery) we propose initiating one full cycle of combined oral contraceptives (COCs) * Corresponding author. Tel.: ⫹1-919-405-1473; fax: ⫹1-919-5447261. E-mail address: [email protected] (J. Stanback).
immediately. This approach has two benefits: it provides effective contraception to the client, and in addition, it can serve as a pregnancy test. At the end of 21 days, the woman would cease taking active pills for a week, as usual. Bleeding at that time would indicate no pregnancy, and the woman could continue COCs or switch to a different method. Lack of bleeding would indicate a possible pregnancy, and the woman would be instructed to stop taking the pills and seek a pregnancy test. She could also be counseled ahead of time about where to seek prenatal care or other options. Pill provision to breast-feeding women after 6 months post-partum is safe. Although COCs given in the first 6 months post-partum may alter the quantity or quality of breast milk, after 6 months, any possible changes are considered subordinate to the advantages of providing effective contraception [3]. And if the woman turns out to have had an unrecognized pregnancy, the likelihood of harm from exposure of the fetus to the hormones in combined pills is negligible [4]. One unresolved issue is the accuracy of this approach for detecting pregnancy. A false-positive result could occur if the woman is not pregnant but has no bleeding after a three-week course of COCs. We expect, however, that the estrogen in the pills would usually prevent such a result. A policy of performing a pregnancy test for those clients who have no withdrawal bleed could resolve these situations. A false-negative result (the woman is pregnant but has a bleeding episode anyway) is potentially more serious because the client would continue taking COCs during her pregnancy. However, as noted above, COCs are not dangerous in pregnancy, to either the mother or the fetus. Moreover, false-negative results would likely be very rare, both because high levels of progesterone in pregnant women would usually preclude bleeding and because few amenorrheic breast-feeding women are actually pregnant. For example, by multiplying pregnancy rates from late post-partum women in our Kenya study (2.8%) by the false-negative rate from a 1976 study of the use of an
0010-7824/02/$ – see front matter © 2002 Elsevier Science Inc. All rights reserved. PII: S 0 0 1 0 - 7 8 2 4 ( 0 2 ) 0 0 3 6 3 - 3
296
J. Stanback et al. / Contraception 66 (2002) 295–296
injected combined estrogen and progestin preparation as a pregnancy test (4 false-negatives per 74 pregnancies) [5], we estimate that, had the proposed approach been applied in our study population, only about 0.15% of the women would have had undetected pregnancies. More research quantifying the test characteristics of this approach as a pregnancy test is clearly needed. In the meantime, in settings where better methods of ruling out pregnancy are simply not available, we suggest that our modified approach to hormonal pregnancy testing (using a full 21-day cycle) is preferable to the practices of using a shorter course of COCs as a hormonal pregnancy test [6] or, worse, denying contraception. In the poorest countries, a woman’s lifetime risk of death from complications of pregnancy, childbirth, or unsafe abortion is greater than one in 10 [7]. Even where the risks are not so great, this option, which gets effective, safe contraception to the women who need it most, is desirable. Few amenorrheic women seeking contraception are pregnant and, for the few who are, the risks of using COCs are minimal and vastly outweighed by the advantages of this strategy to the multitudes who are not. Ironically, we ourselves have recently argued in print that the widespread use of estrogen as a hormonal pregnancy test in Africa is obsolete and should cease [8]. But in low-resource settings where modern pregnancy testing kits are not available, the strategy of providing COCs to amenorrheic women after 6 months post-partum makes good sense.
Acknowledgments Funding for this work was provided by the United States Agency for International Development (USAID) but does not necessarily reflect USAID’s views.
References [1] Stanback J, Thompson A, Hardee K, Janowitz B. Menstruation requirements: a significant barrier to contraceptive access in developing countries. Stud Fam Plann 1997;28:245–50. [2] Stanback J, Qureshi Z, Sekadde-Kigondu C, Gonzalez B, Nutley T. Checklist for ruling out pregnancy among family-planning clients in primary care. Lancet 1999;354:566. [3] World Health Organization. Improving access to quality care in family planning: medical eligibility criteria for contraceptive use, 2nd edn. Geneva: World Health Organization, 2000. [4] Bracken MB. Oral contraception and congenital malformations in offspring: a review, and meta-analysis of prospective studies. Obstet Gynecol 1990;76(3 Pt 2):552–7. [5] Vengadasalam D, Lean TH, Kessel E, Berger GS, Miller ER. Estrogen-progesterone withdrawal bleeding in diagnosis of early pregnancy. Int J Gynaecol Obstet 1976;14:348 –52. [6] Mtawali G, Muhuhu P, Angle M, Lea J. Pregnancy diagnosis, and contraception. Africa Health 1990;13:36 –7. [7] Population Action International. The PAI report Card 2001: a world of difference: sexual, and reproductive health, and risks. Washington, DC, 2001. [8] Stanback J, Raymond E. Hormonal pregnancy tests in sub-Saharan Africa. Am J Public Health 2001;91:1614 –5.
Short communication
Hormonal pregnancy test redux John Stanback*, Elizabeth Raymond, Barbara Janowitz Family Health International, Research Triangle Park, NC 27709, USA Received 20 March 2002; received in revised form 2 May 2002; accepted 19 June 2002
Every day, health providers in many poor countries face a difficult choice when new clients request hormonal contraception. Providers have been trained that pregnancy must be excluded before hormonal methods are dispensed. However, in some clinics, up to half of new clients may be breast-feeding mothers with lactational amenorrhea. In the many areas where pregnancy tests are not routinely available, providers must either delay initiation of contraception until the client begins menstruating or rule out pregnancy by other means. Our previous research has shown that in many countries, providers often send post-partum women home without an effective method, putting them at risk of unintended and often dangerous pregnancies [1]. Excluding pregnancy by a history and exam is a good option [2] for the majority of new clients, including postpartum women who present for services within the first 6 months after delivery. But ruling out pregnancy is more difficult for women who present between 6 months postpartum and the onset of menses, sometimes a year or more post-partum, when fewer women remain abstinent and lactational infecundability can no longer be relied upon to exclude pregnancy. In a study we conducted in Kenya, providers were able to rule out pregnancy for 98% of clients who were within 6 months post-partum, but for only 46% of amenorrheic clients presenting more than 6 months after delivery. In fact, though, very few of the latter group (less than 3%) were actually pregnant. Given the large numbers of women affected, and the risks inherent in pregnancy and childbirth in the countries where they live, amenorrheic women presenting for contraception beyond 6 months post-partum need a new option. If pregnancy cannot be excluded by pregnancy test or by history (e.g., by determining that the woman has not had unprotected intercourse since delivery) we propose initiating one full cycle of combined oral contraceptives (COCs) * Corresponding author. Tel.: ⫹1-919-405-1473; fax: ⫹1-919-5447261. E-mail address: [email protected] (J. Stanback).
immediately. This approach has two benefits: it provides effective contraception to the client, and in addition, it can serve as a pregnancy test. At the end of 21 days, the woman would cease taking active pills for a week, as usual. Bleeding at that time would indicate no pregnancy, and the woman could continue COCs or switch to a different method. Lack of bleeding would indicate a possible pregnancy, and the woman would be instructed to stop taking the pills and seek a pregnancy test. She could also be counseled ahead of time about where to seek prenatal care or other options. Pill provision to breast-feeding women after 6 months post-partum is safe. Although COCs given in the first 6 months post-partum may alter the quantity or quality of breast milk, after 6 months, any possible changes are considered subordinate to the advantages of providing effective contraception [3]. And if the woman turns out to have had an unrecognized pregnancy, the likelihood of harm from exposure of the fetus to the hormones in combined pills is negligible [4]. One unresolved issue is the accuracy of this approach for detecting pregnancy. A false-positive result could occur if the woman is not pregnant but has no bleeding after a three-week course of COCs. We expect, however, that the estrogen in the pills would usually prevent such a result. A policy of performing a pregnancy test for those clients who have no withdrawal bleed could resolve these situations. A false-negative result (the woman is pregnant but has a bleeding episode anyway) is potentially more serious because the client would continue taking COCs during her pregnancy. However, as noted above, COCs are not dangerous in pregnancy, to either the mother or the fetus. Moreover, false-negative results would likely be very rare, both because high levels of progesterone in pregnant women would usually preclude bleeding and because few amenorrheic breast-feeding women are actually pregnant. For example, by multiplying pregnancy rates from late post-partum women in our Kenya study (2.8%) by the false-negative rate from a 1976 study of the use of an
0010-7824/02/$ – see front matter © 2002 Elsevier Science Inc. All rights reserved. PII: S 0 0 1 0 - 7 8 2 4 ( 0 2 ) 0 0 3 6 3 - 3
296
J. Stanback et al. / Contraception 66 (2002) 295–296
injected combined estrogen and progestin preparation as a pregnancy test (4 false-negatives per 74 pregnancies) [5], we estimate that, had the proposed approach been applied in our study population, only about 0.15% of the women would have had undetected pregnancies. More research quantifying the test characteristics of this approach as a pregnancy test is clearly needed. In the meantime, in settings where better methods of ruling out pregnancy are simply not available, we suggest that our modified approach to hormonal pregnancy testing (using a full 21-day cycle) is preferable to the practices of using a shorter course of COCs as a hormonal pregnancy test [6] or, worse, denying contraception. In the poorest countries, a woman’s lifetime risk of death from complications of pregnancy, childbirth, or unsafe abortion is greater than one in 10 [7]. Even where the risks are not so great, this option, which gets effective, safe contraception to the women who need it most, is desirable. Few amenorrheic women seeking contraception are pregnant and, for the few who are, the risks of using COCs are minimal and vastly outweighed by the advantages of this strategy to the multitudes who are not. Ironically, we ourselves have recently argued in print that the widespread use of estrogen as a hormonal pregnancy test in Africa is obsolete and should cease [8]. But in low-resource settings where modern pregnancy testing kits are not available, the strategy of providing COCs to amenorrheic women after 6 months post-partum makes good sense.
Acknowledgments Funding for this work was provided by the United States Agency for International Development (USAID) but does not necessarily reflect USAID’s views.
References [1] Stanback J, Thompson A, Hardee K, Janowitz B. Menstruation requirements: a significant barrier to contraceptive access in developing countries. Stud Fam Plann 1997;28:245–50. [2] Stanback J, Qureshi Z, Sekadde-Kigondu C, Gonzalez B, Nutley T. Checklist for ruling out pregnancy among family-planning clients in primary care. Lancet 1999;354:566. [3] World Health Organization. Improving access to quality care in family planning: medical eligibility criteria for contraceptive use, 2nd edn. Geneva: World Health Organization, 2000. [4] Bracken MB. Oral contraception and congenital malformations in offspring: a review, and meta-analysis of prospective studies. Obstet Gynecol 1990;76(3 Pt 2):552–7. [5] Vengadasalam D, Lean TH, Kessel E, Berger GS, Miller ER. Estrogen-progesterone withdrawal bleeding in diagnosis of early pregnancy. Int J Gynaecol Obstet 1976;14:348 –52. [6] Mtawali G, Muhuhu P, Angle M, Lea J. Pregnancy diagnosis, and contraception. Africa Health 1990;13:36 –7. [7] Population Action International. The PAI report Card 2001: a world of difference: sexual, and reproductive health, and risks. Washington, DC, 2001. [8] Stanback J, Raymond E. Hormonal pregnancy tests in sub-Saharan Africa. Am J Public Health 2001;91:1614 –5.