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Use of a Checklist to Rule out Pregnancy: a Systematic Review☆ ⁎ Naomi K

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Use of a Checklist to Rule out Pregnancy: a Systematic Review☆ ⁎ Naomi K Contraception 87 (2013) 661–665 Review article Use of a checklist to rule out pregnancy: a systematic review☆ ⁎ Naomi K. Tepper , Polly A. Marchbanks, Kathryn M. Curtis Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA 30341, USA Received 6 July 2012; revised 27 July 2012; accepted 7 August 2012 Abstract Background: Safe initiation of contraceptive methods requires that pregnancy be excluded. The World Health Organization has developed a list of criteria to assess pregnancy status. This review was conducted to evaluate the evidence regarding these criteria in excluding pregnancy. Study Design: The PubMed database was searched from database inception through March 2012 for all peer-reviewed articles in any language concerning the performance of a pregnancy checklist compared to urine pregnancy tests. The quality of each study was assessed using the United States Preventive Services Task Force grading system. Results: Four analyses of data from three studies met inclusion criteria as direct evidence. All were diagnostic accuracy studies of fair quality that evaluated the performance of a pregnancy checklist compared with urine pregnancy test to rule out pregnancy. The performance of the checklist varied, with sensitivity ranging from 55–100% and specificity ranging from 39–89%. The negative predictive value was consistent across studies at 99–100%. Conclusion: All four analyses demonstrated high (99–100%) negative predictive value for the pregnancy checklist. Published by Elsevier Inc. Keywords: Pregnancy checklist; Pregnancy test; Contraception; Systematic review 1. Introduction following criteria: has not had intercourse since last normal menses, has been correctly and consistently using a reliable Safe initiation of contraception relies on accurately method of contraception, is within the first 7 days after excluding pregnancy. Pregnancy tests are reliable, inexpen- normal menses, is within 4 weeks postpartum for non- sive and easy to administer. However, they may not always lactating women, is within the first 7 days postabortion or be available or affordable, particularly in low resource miscarriage or is fully or nearly fully breastfeeding, settings, and they may not detect very early pregnancies. One amenorrheic, and less than 6 months postpartum [2]. These alternative to a pregnancy test is physical examination; criteria have been developed into a pregnancy checklist for however, this is not always feasible and is not reliable until use by family planning providers in excluding pregnancy [3]. 8–10 weeks following the last menstrual period [1]. The The US Centers for Disease Control and Prevention is World Health Organization's (WHO) Selected Practice currently undergoing a formal process to adapt the WHO Recommendations for Contraceptive Use (SPR) provides SPR for use in the United States. The objective of this guidance on the safe and effective use of contraceptive systematic review is to examine the evidence regarding the methods [1]. The WHO SPR states that certain criteria can be accuracy of the listed criteria to exclude pregnancy. used to assess pregnancy status. A provider can be reasonably sure that a woman is not pregnant if she has no signs or symptoms of pregnancy and meets any of the 2. Methods ☆ In order to assess the accuracy of a pregnancy checklist, Disclaimer: The findings and conclusions in this article are those of we searched the PubMed database for all peer-reviewed the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. articles in any language published from database inception ⁎ Corresponding author. Tel.: +1 770 488 6506; fax: +1 770 488 6391. through March 2012 using the search term “pregnancy E-mail address: [email protected] (N.K. Tepper). checklist.” Reference lists from articles identified by the 0010-7824/$ – see front matter. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.contraception.2012.08.007 662 Table 1 Evidence for accuracy of a pregnancy checklist to exclude pregnancy Author, year, Study design Population Results Strengths Weaknesses Quality location, source of support Stanback et al. [7], 1999 Diagnostic Convenience sample of 1852 non-menstruating Checklist Dipstick test Large sample size Did not provide Fair Kenya accuracy family-planning clients: Used standardized independent information Pregnant Not pregnant Supported by USAID study 59% postpartum and lactating tool to assess on accuracy of urine 37% between menses Pregnant 14 209 pregnancy status pregnancy test 4% recent abortions Not pregnant 8 1621 N.K. Tepper et al. / Contraception 87 (2013) 661 All women received commercial dipstick Sensitivity=64% pregnancy test Specificity=89% Positive predictive value=6% Negative predictive value=99% Prevalence of pregnancy=1% Stanback et al. [5], 2006 Diagnostic Secondary analysis of previously collected With signs and symptoms of pregnancy (uterine Large sample size Small numbers of women Fair Kenya accuracy data (Stanback et al. [7], 1999) to assess mass, nausea, abdominal pain, spitting, vomiting, Used standardized reporting signs and symptoms Supported by USAID study signs and symptoms of pregnancy engorged breasts, missed periods, “giddiness”, tool to assess of pregnancy “laziness”): pregnancy status Did not provide independent Checklist Dipstick test information on accuracy of urine pregnancy test Pregnant Not pregnant Pregnant 14 209 Not pregnant 8 1621 Sensitivity=64% (95% CI 44–84%) – Specificity=89% (95% CI 87–90%) 665 Positive predictive value=6% (95% CI 3–9%) Negative predictive value=99% (95% CI 99–100%) Prevalence of pregnancy=1% Prevalence of signs and symptoms=1.5% Without signs and symptoms of pregnancy: Dipstick test Pregnant Not pregnant Pregnancy not ruled out 12 191 Pregnancy ruled out 10 1639 Sensitivity=55% (95% CI 34–75%) Specificity=90% (95% CI 88–91%) Positive predictive value=6% (95% CI 3–9%) Negative predictive value=99% (99–100%) Stanback et al. [6], 2008 Diagnostic 263 non-menstruating women desiring Checklist Dipstick test Used standardized Small sample size Fair Nicaragua accuracy oral contraceptives tool to assess Did not provide independent Pregnant Not pregnant Supported by USAID study Postpartum women excluded pregnancy status information on accuracy of All women received urine dipstick Pregnant 3 103 urine pregnancy test pregnancy test Not pregnant 0 157 Sensitivity=100% (95% CI 29–100%) Specificity=60% (95% CI 54–66%) Positive predictive value=3% (95% CI 1–8%) Negative predictive value=100% (95% CI 98–100%) Prevalence of pregnancy=1% Torpey et al. [8], 2010 Diagnostic Convenience sample of 535 Checklist Dipstick test Sample size calculation Did not provide independent Fair Zambia accuracy non-menstruating women from 20 ART demonstrated that study information on accuracy of Pregnant Not pregnant Supported by study sites (1 woman excluded due to absence of had adequate power urine pregnancy test FHI/Zambia pregnancy test results) Pregnancy not ruled out 20 314 Used standardized Prevention Care Inclusion criteria: all women initiating ART Pregnancy ruled out 2 198 tool to assess b and Treatment (CD4 200, WHO stage IV regardless of Sensitivity=90.9% (90% CI 74.1–98.4%) pregnancy status N.K. Tepper et al. / Contraception 87 (2013) 661 b Partnership CD4, or WHO stage III and CD4 350) Specificity=38.7% (90% CI 35.1–42.4%) and USAID Exclusion criteria: self-report of pregnancy, Positive predictive value=6% (90% CI 4–8.6%) currently menstruating, WHO stage I, II, Negative predictive value=99% or III with no CD4 count (90% CI 96.9–99.8%) All women received urine dipstick Prevalence of pregnancy=4% pregnancy test Abbreviations: ART, antiretroviral therapy; CI, confidence interval; FHI, Family Health International; USAID, United States Agency for International Development; WHO, World Health Organization. symptoms was includedthe did checklist not when markedly the information differ on from pregnancy the signs and 2 months, pain, spitting, vomiting, engorged breasts, missed(4 periods of for whom were pregnant): uterinefollowing mass, signs nausea, abdominal and symptomschecklist were recorded in 27symptoms women of pregnancy alongin with the order other criteria to in the examinemore the than 99%. valuepositive of predictive value assessing 6%,to and signs negative be predictive and value The the performance of the following: checklist inpregnancy this sensitivity (those study was detected calculated 64%, bycommercial the specificity dipstick pregnancy 89%, test)abortions. pregnancy was All women 1%. test. were administeredlactating, The the 37% checklist prevalence and were a tion between of were menses, enrolled and inclinics, the 4% 1852 study; had non-menstruating 59% recent sample women were seeking postpartum of contracep- and seven family-planning clinics WHO criteria a pregnancy checklist thatwhich was was considered based to on becomparing the either a reference pregnancy the standard. checklist current All to used urine pregnancy testing, ( analyses from 3 studies metpregnancy inclusion criteria checklist for this review identified 453 articles, of3. which Results 4 characteristics. to heterogeneity among studies with respect2.3. Data to synthesis subject tic accuracy studies Preventive Services Task Force gradingpiece system for of diagnos- evidenceassessed was by assessed all using authors. the The United quality States 2.2. of Study quality each assessment individual but did not reportStudies its were accuracy. excluded if theypregnancy
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