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PRODUCT BRIEF Caucus on New and Underused Reproductive Technologies

Pregnancy tests for planning

Description • Early access to tests was associated with earlier access to antenatal care or services in a Low-cost, accurate urine pregnancy tests are a simple study in South Africa.11 tool that can be used to rule out pregnancy for some women and help increase access to same-day provision of family planning methods.* Guidance from the World Efficacy Health Organization (WHO) indicates that, for hormonal contraceptives, a woman can initiate a method if her Proper use and accuracy heath care provider is “reasonably certain she is not Two types of urine pregnancy tests are currently available. 1 pregnant.” Because many family planning providers Both types employ test strips that detect human chorionic in developing countries rely on the presence of menses gonadotropin (hCG) levels in the urine to determine the to rule out pregnancy among clients, women who are likelihood of pregnancy. In the first type, the user holds not menstruating at the time they visit the clinic are a test strip in the urine stream to capture a mid-stream 2,3 routinely denied same-day provision of family planning. sample. In the second type, the user captures a urine Studies show that anywhere from 5 to 50 percent of non- sample in a cup and then dips a test strip into the cup 4,5 menstruating women are denied services, even though (known as a “dip strip test”). With both types, the user several studies have shown that very few of these women only has to wait a few minutes before viewing the results 6,7 are actually pregnant. Non-menstruating women are window on the test strip, which indicates whether the user usually told to return to the clinic during their next is likely pregnant. Most tests also have a control indicator menses, but without family planning these women remain to indicate whether the test is working properly. Dip strip at risk of unplanned pregnancy in the interim. tests are less expensive than the mid-stream tests and Pregnancy tests can help remove these barriers. They are typically used in low-resource settings. Blood tests can be used to rule out pregnancy when a woman is for pregnancy status are also available and very amenorrheic, such as when she is postpartum but not effective, but their cost remains prohibitive in most protected from pregnancy by the Lactational Amenhorrhea developing countries. 8 Method (LAM), or when she is amenorrheic as a result of Both types of urine have similar accuracy using injectable contraception and returns late for a re- rates, and they are both very accurate when used correctly 9 injection. Also, pregnancy tests should be used to rule out and after enough time has passed since fertilization. pregnancy when women come to the clinic after they have Instructions included with commercially available tests missed their menses. indicate that a client should wait until after the expected In addition to ruling out pregnancy for women seeking date for the next menses has passed before testing. Some family planning, pregnancy tests may offer other over-the-counter tests claim up to 99 percent accuracy one benefits. For example: day after the missed menses. However, studies have shown this claim to be exaggerated12,13,14 and estimate that the • For women seeking health services because they want accuracy is closer to 90 percent on the first day after missed to know their pregnancy status, these contacts may be menses. Accuracy increases as more time elapses after the an ideal “teachable moment” to offer follow-up family missed menses, and the authors of one study estimate 97 planning counseling and provision. percent accuracy seven days after the missed menses.12 • For women who are using progestin-only hormonal Some tests may take as long as two weeks after the day of contraceptives, pregnancy testing can reassure those who expected menses to be effective. worry that they are pregnant when they experience the The body begins producing the hCG hormone as soon as 10 normal side effect of amenorrhea. a fertilized egg attaches to the uterine wall (usually 6 to 12 days after fertilization), and hCG levels continue increasing

* A urine pregnancy test will not be effective in determining pregnancy status in all cases, including for women who are between two normal menses. It is recommended that the Pregnancy Checklist be used by family planning programs in conjunction with pregnancy tests (see the “Current program use” section of this brief for more information). CAUCUS ON NEW AND UNDERUSED REPRODUCTIVE HEALTH TECHNOLOGIES PRODUCT BRIEF of pregnancy urine the test include error user (whether than less sensitive variables strips. Other affecting accuracy of and inurine hCG therefore can pregnancy detect earlier sensitivity means that test the strip can lower detect levels relatedis also to sensitivity the of test the higher strip used; of women into fall category. this (DMPA) study have trials shown approximately 2percent are not enough high yet).** medroxyprogesterone Depot for pregnancy urine the test to it detect (i.e., levels hCG she may alreadyperiods, be pregnant, but it isearly too awomanwhen arrives at two clinic the menstrual between attaches egg fertilized the to uterine the wall. women when timingin the between ovulate and when of pregnancy tests is often due the to natural variations as pregnancy the progresses. The variabilitythe accuracy in which iswhich aserious complication. *** In of case IUD, the important it is very out to rule pregnancy an inserting IUDinawoman because is who already pregnant may result , inseptic pregnancy.diagnose after implantation beforeand they period, are expensivethe first menstrual asmissed notedabove, require and laboratory services, are not routinelyused to tests, such** Certain as aquantitative pregnancy blood test, can measure tests level While of exact blood. the inthe these can pregnancy hCG detect afew days for simple, the low-tech Pregnancy to Checklist help developing countries, there an is important still role more widely available infamily planning programs in It is important to note that, evenas pregnancy tests become less test. than US$0.10 per programs and donors can now purchase tests these for the accurate dip strip tests significantly, has decreased and are perceived asexpensive. too However, price the of highly ofpart routine tests these because family planning services Few low-resource countries include pregnancy testing as Current program/sector use anbe issue. stock-outs of family planning were methods reported to werewho was low amethod denied at baseline, and effect; however,setting,thethis in number of clients offered. Asimilar study in Ghana did not showsamethe incontrola method sites where no pregnancy tests were clients were more than four more times likely denied to be controlin the group. This meansthat non-menstruating percentage the while remained unchanged at 17percent from 15percent at to baseline 4percent at follow-up, menstruating women were who dropped amethod denied pregnancy tests were available, proportion the of non- was substantially reduced. numberthe of women contraceptive denied services pregnancyfree tests at government family planning clinics, A recent study inZambia demonstrated that, by providing provision family of planning in increasing access to same-day Efficacy medicines, and excessive drinking amounts of water. instructionsthe were followed correctly), certain taking 10,16

10,16 17

In intervention sites where 15 The accuracy the of test The accuracy 12 Therefore,

outweigh any potential risks associated with denial. benefitsthe likelyof increased access these methods to to hormonal family planning methods.*** to either apregnant woman or afetus from exposure In addition, according to WHO, no known harm occurs pregnancy test instead should used of be checklist. the a woman a has already period, her menstrual missed checklist the cases, should If used. menses; inthese be with womennot used be presenting two normal between week or therefore twoand afterperiod amissed should pregnancy tests cannot pregnancy detect earlier than a In addition, tools both have limitations. clinical Urine outto rule pregnancy, apregnancy test should used. be injectables, checklist the first should used be and, if it fails postpartum or she has discontinued of use progestin-only For example, ifwoman is amenorrheic she because is and apregnancy use then test only necessary. when protocol is to and ahistory take checklist the use first, are relatively inexpensive, are they not apreferred free, so inmultipleused countries. Recommendations, and validated tool the has and been outruling pregnancy from Practice WHO the Selected includes of questions aseries on criteria the for based providers out rule pregnancy. cases, the process the cases, is usually simple and straightforward. registration for pregnancy tests before importation; in these approval at national the level. Some countries dorequire oftenthey do not require any additional regulatory byset International the Organization for Standardization, CE mark or manufacturer the equivalent meets standards European Union member states. If pregnancy tests have a mandatory conformity mark by for used devices medical Pregnancy tests are often availablewith aCE mark, a Registration status distributorparty or international procurement group. purchase pregnancy tests are to advised work with athird- Unitedthe States. Typically, programs country that want to including , Canada, , South Korea, Taiwan, and tests and located middle-, inhigh-, low-income countries, There are many manufacturers and suppliers of pregnancy Manufacturer/supplier woman presents for contraceptive services. to provide effective contraception samethe on day that a many low-resource effort countries, shouldbe made every Given maternal high the mortality and morbidity rates in 5,6 Although pregnancy tests 18,19 The PregnancyChecklist ,20 Therefore, 16

2 CAUCUS ON NEW AND UNDERUSED REPRODUCTIVE HEALTH TECHNOLOGIES PRODUCT BRIEF 3. 2. 1. References volumes procured. test.US$0.10 per Urine pregnancy dip strip tests are available for less than Public-sector price agreements endorsement by theCoalition orits wider membership. For additional information, please contact health sectors. Responsibility for theselectionand contents of theproduct briefs rests solely with theCaucus and does not imply broaden thediscussion within theCoalition of reproductive health technologies that are not well integrated into thepublic orcommercial Technologies, athematic group established under theauspices of theReproductive Health Supplies Coalition. The Caucus’ aimis to This publication forms part of aseries of technical briefs, written by members of theCaucus onNewand Underused Reproductive Health http://www.rhsupplies.org/working-groups/caucus-on-newunderused-rh-technologies.html For more information ontheCaucus onNewand Underused RHTechnologies, please visit our web page at 9. 8. 7. 6. 5. 4. Stanback J, Thompson A, Hardee K, Janowitz B. Menstruation 345. access to family planning. Shelton, JD. Angle MA,Jacobstein, Medical RA. to barriers WHO;Geneva: 2004. Recommendations for Contraceptive Use (second edition) World Health Organization (WHO). 2007;33(2):66–74. discontinuation. re-injections and inSouth its Africa relation to unintentional Janowitz B, Stanback J, Buga G.Timeliness of contraceptive Baumgartner J, Morroni Otterness C,Mlobeli R, C,Myer L, andand JHU-CCP WHO; Geneva: 2011. Family Planning: Global A Handbook for Providers often,day and night;babythe 3) thanis less six months old. returned; baby 2)the or is fully nearly breastfed fully and is fed as three conditions are met: 1)Amother’s menses have not postpartum women up to sixmonths after as longchildbirth AmenorrheaLactational Method effective can be (LAM) for WHO, Johns Hopkins Bloomberg of School . The 2008;23(2):116–118. clients inNicaragua. of ajobaid out to rule pregnancy among family planning Stanback J, Nanda Y, K,Ramirez Rountree W. Validation clients care. inprimary T. for Checklist out ruling pregnancy among family planning Stanback J, Qureshi Z, Sekadde-Kigondu B, C,Gonzalez Nutley Planning Family clients: impact the of achecklist inthree countries. C, Traore M.Ruling out pregnancy among family planning Stanback J, Diabate F, Dieng T, Duate deMorales T, Cummings 2007;19(2):68–73. an experiment. Improving adherence to family planning guidelines inKenya: Stanback J, Brechin J, Lynam P, Ruto C,Cummings S. 1997;28(3):245–250. in developing countries. requirements: asignificant barrier to contraceptive access 17 International Journal for Quality in .2005;36(4):311–15. Typically, prices are dependent on the International Family Planning Perspectives Pan American Journal of Public Health The Lancet The Studies in Family Planning in Studies The Lancet The . 1999;354(9178):566. . 1992;340(8,831):334– Selected Practice Practice Selected . Baltimore . Studies in in Studies . . . . 17. 16. 15. 14. 13. 12. 11. 10. 20. 19. 18. of Contraceptives, Productive Health Kits, Pharmaceutical AccessRH, Fund (UNFPA). Brief Research Contraceptive Findings Services: from Zambia and Ghana: FHI 360. 2008;77(1):40–43. for approach anew to contraceptive follow-up. testing inan urban family planning clinic: promising results Estes J, CM,Ramirez Tiezzi L,WesthoffSelf C. pregnancy Chemistry and diagnostic evaluation by 638volunteers. feasibility of pregnancy home-use tests: laboratory validation Daviaud J, Fournet D, Ballongue C,etal. Reliability and Journal of &Gynecology home pregnancy tests at of time the menses. missed L,Khanlian S,SuttonCole J, Davies W. S,Rayburn Accuracy of 2001;286(14):1759–1761. period. menstrual Natural limits of pregnancy testing inrelation to expected the Wilcox A,Bairs DD, Dunson D, McChesney Weinberg R, C: across-sectional study.in South Africa: in facilitating access to antenatal care and abortion services Morroni J. C,Moodley The role of urine pregnancy testing Washington, July DC: 19,2012. ResearchPROGRESS Findings and Next Steps” meeting. and Program Implications FHI 360. Edition WHO. 2012;S0010-7824(12):00734–2. outto asystematic rule pregnancy: review. Tepper NK,Marchbanks PA, Curtis KM.Use of achecklist and JHU-CCP WHO,Geneva: 2011. planning: global a handbook for providers of Public Health/Center for Communication Programs. World Health Organization, Johns Hopkins Bloomberg School 5ca8455a3c9c. myaccessrh.org/documents/10157/ba5b4329-6d6e-4205-968c- Products, and Medical Equipment . Geneva: WHO;. Geneva: 2010. Medical Eligibility Criteria for Contraceptive Use. Fourth Free Pregnancy Testing Could Reduce Denial of Findings Research New Family Planning Postpartum . 1993;39:53–59. 2006;6:26. . Research Triangle Park, NC: FHI360;2013. Journal of the American Medical Association [email protected] . “Postpartum Family Planning, . Available at: http://www. This brief was last updated May 2013 May updated waslast brief This . 2004;190:100–105. BMC Pregnancy and . Baltimore and . Contraception Clinical Clinical Contraception . American American Catalog Family Family .

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