Assessment of birth defects according to maternal therapy among infants in the Women and Infants Transmission Study.

BACKGROUND: To evaluate rate and types of birth defects according to timing of antiretroviral exposure among babies born to HIV-infected women. METHODS: Anomalies identified during the prenatal, neonatal, or follow-up period were classified using criteria of the Antiretroviral Pregnancy Registry. Antiretroviral use was classified as none, second or third trimester only, or first trimester. RESULTS: From January 1, 1990 through June 30, 2004, 2527 live births (LBs) occurred to 2353 women. Defects were identified in 90 babies for a rate of 3.56 defects per 100 LBs. The rate of defects was 3.19 per 100 LBs (24 of 752 LBs) with first-trimester antiretroviral exposure, 3.54 per 100 LBs (41 of 1158 LBs) with exposure later in pregnancy, and 4.05 of 100 LBs (25 of 617 LBs) with no antiretroviral use. Only genital abnormalities, specifically hypospadias, were significantly increased among babies born to women with first-trimester exposure to antiretrovirals (7 of 382 male LBs) compared with the 2 other groups (2 of 892 male LBs; P = 0.007). On logistic regression, use of zidovudine in the first trimester was associated with hypospadias (adjusted odds ratio = 10.68, 95% confidence interval: 2.11 to 54.13; P = 0.004). CONCLUSIONS: In general, data were reassuring, although the frequency of exposure to newer agents was limited. The increased risk of hypospadias after first-trimester exposure must be explored, because this association has not been detected previously.

Predictors of repeat pregnancy among HIV-1-infected women.

BACKGROUND: In the Women and Infants Transmission Study (WITS), a prospective cohort study of HIV-infected pregnant women at six US mainland and Puerto Rican sites, changes in the HIV-1 epidemic have included higher income, better education, and better-controlled HIV disease among more recently enrolled women. Because these changes may alter the reproductive patterns of these women an awareness of these women's current reproductive behaviors is essential. We examined predictors of repeat pregnancy among HIV-1-infected women enrolled in the Women and Infants Transmission Study (WITS). METHODS: Women enrolled in WITS without a history of sterilization were included. Using bivariate and multivariate analyses, predictors of a repeat pregnancy were modeled. Changes in risk factors for repeat pregnancy over time were examined and important predictors of repeat pregnancy were determined. RESULTS: Of 2246 eligible women, 22% had more than one WITS-enrolled pregnancy. In bivariate analyses, risk of repeat pregnancy was associated with younger age, lower educational status, higher CD4%, and lower viral loads. There was little change in risk factors for repeat pregnancy over time. CONCLUSIONS: HIV-1-infected women who are younger and healthier are more likely to have more than one pregnancy. Factors associated with repeat pregnancy among HIV-1-infected women have remained stable over time. Awareness of these factors will better equip healthcare providers to address the reproductive needs of HIV-1-infected women.

Improved obstetric outcomes and few maternal toxicities are associated with antiretroviral therapy, including highly active antiretroviral therapy during pregnancy.

Data from 2543 HIV-infected women were analyzed to correlate antiretroviral therapy (ART) used during pregnancy with maternal and pregnancy outcomes. ART was analyzed according to class of agents used and according to monotherapy versus combination ART containing neither protease inhibitors (PIs) nor nonnucleoside reverse transcriptase inhibitors versus highly active ART. Timing of ART was classified according to early (recorded at or before 25-week gestation study visit) and late (recorded at 32-week gestation or delivery visit) use. Maternal outcomes assessed included hematologic, gastrointestinal, neurologic, renal, and dermatologic complications; gestational diabetes; lactic acidosis; and death. Adverse pregnancy outcomes assessed included hypertensive complications; pre-term labor or rupture of membranes; preterm delivery (PTD); low birth weight; and stillbirth. Logistic regression analyses controlling for multiple covariates revealed ART to be independently associated with few maternal complications: ART use was associated with anemia (odds ratio [OR] = 1.6, 95% confidence interval [CI]: 1.1-2.4), and late use of ART was associated with gestational diabetes (OR = 3.5, 95% CI: 1.2-10.1). Logistic regression analyses revealed an increase in PTD at <37 weeks for 10 women with late use of ART not containing zidovudine (ZDV; OR = 7.9, 95% CI: 1.4-44.6) and a decrease in adverse pregnancy outcomes as follows: late use of ART containing ZDV was associated with decreased risk for stillbirth and PTD at <37 weeks (OR = 0.06, 95% CI: 0.02-0.18; OR = 0.5, 95% CI: 0.3-0.8, respectively), and ART containing nucleoside reverse transcriptase inhibitors but not ZDV during early and late pregnancy was associated with decreased risk for PTD at <32 weeks (OR = 0.3, 95% CI: 0.2-0.7). Benefits of ART continue to outweigh observed risks.