Performance of a checklist to exclude pregnancy at the time of contraceptive initiation among women with a negative urine pregnancy test. Min, J.; Buckel, C.; Secura, G. M.; Peipert, J. F.; and Madden, T. Contraception, 91(1):80--84, January, 2015.
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OBJECTIVE: Our objective was to measure the sensitivity and specificity of a six-item "pregnancy checklist" at excluding early- or luteal-phase pregnancy among women with a negative urine pregnancy test who were initiating contraception. STUDY DESIGN: This was a secondary analysis of the Contraceptive CHOICE Project, a prospective cohort study of 9256 women in the St. Louis region. Women who had a negative urine pregnancy test on the day of enrollment were included in this analysis. Women with a positive urine pregnancy test or without urine pregnancy testing were excluded. We identified all luteal-phase pregnancies that occurred among women with a negative urine pregnancy test. We calculated the sensitivity, specificity, positive predictive value and negative predictive value (NPV) and likelihood ratios of the pregnancy checklist for excluding luteal-phase pregnancies. RESULTS: There were 6929 women included in this analysis; 69% of these women met at least one checklist criterion to exclude pregnancy ("negative screen"). There were 36 luteal-phase pregnancies (0.5%) subsequently diagnosed among women with a negative urine pregnancy test. The sensitivity and specificity of the checklist were 77.7% and 69.1%, respectively. The NPV of the checklist was 99.8% and the positive predictive value was 1.3%. CONCLUSION: Among women with a negative urine pregnancy test, the pregnancy checklist can be used to safely exclude more than 99% of early pregnancies at the time of contraceptive initiation. IMPLICATIONS: In patients with a negative urine pregnancy test, a pregnancy checklist using six criteria based on patient history has high NPV in excluding early pregnancy. This checklist can be used to facilitate same-day initiation of contraceptive methods, including long-acting reversible contraception. Although the checklist had a high false positive rate, initiation of contraception should not be delayed in women with a "positive screen." Rather women who desire an intrauterine device or implant can be "bridged" with a shorter-acting method until pregnancy can be excluded.
@article{min_performance_2015,
	title = {Performance of a checklist to exclude pregnancy at the time of contraceptive initiation among women with a negative urine pregnancy test},
	volume = {91},
	issn = {1879-0518},
	doi = {10.1016/j.contraception.2014.08.002},
	abstract = {OBJECTIVE: Our objective was to measure the sensitivity and specificity of a six-item "pregnancy checklist" at excluding early- or luteal-phase pregnancy among women with a negative urine pregnancy test who were initiating contraception.
STUDY DESIGN: This was a secondary analysis of the Contraceptive CHOICE Project, a prospective cohort study of 9256 women in the St. Louis region. Women who had a negative urine pregnancy test on the day of enrollment were included in this analysis. Women with a positive urine pregnancy test or without urine pregnancy testing were excluded. We identified all luteal-phase pregnancies that occurred among women with a negative urine pregnancy test. We calculated the sensitivity, specificity, positive predictive value and negative predictive value (NPV) and likelihood ratios of the pregnancy checklist for excluding luteal-phase pregnancies.
RESULTS: There were 6929 women included in this analysis; 69\% of these women met at least one checklist criterion to exclude pregnancy ("negative screen"). There were 36 luteal-phase pregnancies (0.5\%) subsequently diagnosed among women with a negative urine pregnancy test. The sensitivity and specificity of the checklist were 77.7\% and 69.1\%, respectively. The NPV of the checklist was 99.8\% and the positive predictive value was 1.3\%.
CONCLUSION: Among women with a negative urine pregnancy test, the pregnancy checklist can be used to safely exclude more than 99\% of early pregnancies at the time of contraceptive initiation.
IMPLICATIONS: In patients with a negative urine pregnancy test, a pregnancy checklist using six criteria based on patient history has high NPV in excluding early pregnancy. This checklist can be used to facilitate same-day initiation of contraceptive methods, including long-acting reversible contraception. Although the checklist had a high false positive rate, initiation of contraception should not be delayed in women with a "positive screen." Rather women who desire an intrauterine device or implant can be "bridged" with a shorter-acting method until pregnancy can be excluded.},
	language = {eng},
	number = {1},
	journal = {Contraception},
	author = {Min, Jaspur and Buckel, Christina and Secura, Gina M. and Peipert, Jeffrey F. and Madden, Tessa},
	month = jan,
	year = {2015},
	pmid = {25218500},
	pmcid = {PMC4267981},
	keywords = {Adolescent, Adult, Checklist, Cohort Studies, Contraception, Contraceptive Agents, Female, Contraceptive initiation, Drug Implants, False Negative Reactions, Female, Humans, Illinois, Intrauterine Devices, Luteal Phase, Middle Aged, Missouri, Patient Compliance, Pregnancy, Pregnancy Tests, Pregnancy Trimester, First, Pregnancy checklist, Pregnancy testing, Pregnancy, Unplanned, Prospective Studies, Sensitivity and Specificity, Young Adult},
	pages = {80--84}
}
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