The prevalence of nondefect adverse birth outcomes was estimated, and the relative risks and 95% CI comparing outcomes with prenatal exposure to ZDV‐containing regimens versus exposure to non‐ZDV ARV regimens were calculated. A stillbirth is defined as the death of a fetus occurring at 20 weeks of gestation or more, or for situations in which the gestational age is unavailable, a fetus weighing at least 500 g. The APR defines spontaneous abortion as death of a fetus or expulsion of the products of conception before 20 weeks gestation. The following adverse birth outcomes other than birth defects are included in our analyses: spontaneous and induced abortions, stillbirths, premature births (<37 weeks gestation), very premature births (<32 weeks gestation), low birthweight (LBW <2500 g) and very low birthweight (VLBW <1500 g). If gestational week is inconsistent with exposure dates and/or the date of outcome (outside ± 1 week for the first trimester, outside ± 2 weeks for the second and third trimesters), a corrected estimated delivery date where ultrasound data are available is used. If the date of the last menstrual period is unknown, the estimated delivery date is used. Gestational weeks are calculated starting from the first day of the last menstrual period. 8, 9, 10 We also compare in utero ZDV exposure at any time during pregnancy to in utero non‐ZDV exposure, because drug exposure at any time during pregnancy may be relevant for birth outcomes. Only singleton births are included in the current analysis multiple births such as twin and triplet births are excluded because of the increased risk of adverse outcomes associated with such pregnancies. Although the APR also collects data from clinical trials and retrospective studies, the primary APR cohort is limited to prospectively registered women. The APR has institutional review board (IRB) approval from Western IRB, and was granted a waiver from obtaining informed consent.Ī birth outcome is defined at the time of delivery or fetal loss, or when a defect detected on a prenatal test is reported at enrolment.

Data on maternal risk factors and birth outcomes are also collected. Pregnant women prenatally exposed to any ARV are prospectively registered before the birth outcome being known, and are followed through to the end of the pregnancy. The majority of case reports are from the USA and its territories (77.6%) the remaining reports are from 66 other countries. 7 Briefly, the APR is a pregnancy registry that monitors for early signal of increased risk for birth defects following prenatal exposure to ARVs. The APR is described in detail in a previous analysis. This is a secondary analysis of data from the APR from 1 January 1989 through to 31 July 2013. In this analysis, we examine the association between adverse pregnancy outcomes other than birth defects and the use of ZDV‐containing regimens during pregnancy, compared with non‐ZDV ARV regimens. The full prescribing information for ZDV in the USA suggests that although no differences in pregnancy‐related adverse events between pregnant women with ZDV exposure compared with those with placebo exposure have been observed, animal studies have shown teratogenicity, resulting in a US Food and Drug Administration Pregnancy Category C status. 3 The complete APR interim report is available online at. 6 The prevalence of birth defects among women with first‐trimester ZDV exposure is 3.2% (95% CI 2.7–3.8%). 5 Among first‐trimester ZDV exposures, the APR reports no increase in the risk of overall birth defects, nor in the risk of birth defects in the cardiovascular and genitourinary systems. This proportion is not significantly higher than those reported in the APR's two population‐based comparators, the Metropolitan Atlanta Congenital Defects Program (the Centers for Disease Control and Prevention's birth defects surveillance system) with 2.72 per 100 live births 4 and the Texas Birth Defects Registry with a reported rate of 4.17 per 100 live births. Data from the most recent APR interim report published in June 2014 indicate that the overall prevalence of birth defects following first‐trimester exposure to any ARV monitored by the registry is 2.8 (95% confidence interval : 2.5–3.3) 3, 1. The Antiretroviral Pregnancy Registry (APR) monitors birth defects in pregnant women exposed to ARVs. WHO guidelines for first‐line regimens for HIV‐positive pregnant women include ZDV.

Zidovudine (ZDV) was the first antiretroviral (ARV) to be approved for treatment of HIV/AIDS in the USA.

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