Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial

Abstract

Background: In the multicountry PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor–based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a protease inhibitor regimen, tenofovir/emtricitabine was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks) compared with zidovudine/lamivudine. Methods: We used multivariate logistic regression to further explore these treatment findings, taking into account demographic baseline clinical and postentry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion. Results: Among 3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD. Seventeen percent of newborns were LBW, 1% were very LBW, 17% had PTD, and 3% had very PTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included the following: country, gestational age at entry, maternal age, maternal body mass index, previous PTD, history of alcohol use, baseline HIV viral titer, multiple gestation, and several obstetric risk factors. Conclusions: ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical, and obstetrical risk factors, which were also associated with these outcomes.

Aetiological testing compared with syndromic management for sexually transmitted infections in HIV‐infected pregnant women in South Africa: a non‐randomised prospective cohort study

“…The pregnancy outcomes observed in our study are reflective of the wider South African public healthcare context where the prevalence of stillbirth is 1–3%, and preterm delivery and low birthweight infants occur in 10–25% of pregnancies 38–42 . Our observed association of N. gonorrhoeae infection during pregnancy with low birthweight confirms previous reports 43,44 .…”

Adverse Pregnancy Outcomes Among HIV-positive Women in the Era of Universal Antiretroviral Therapy Remain Elevated Compared With HIV-negative Women

“…Data on the association of ART with preterm birth are conflicting, and some studies suggest that ART regimens may differ in their association with preterm birth. 11,[26][27][28][29][30][31] Most of the HIVpositive women in our cohort were on a combination of TDF, 3TC and EFV, which has appeared to have a lower rate of adverse pregnancy outcomes than other ART regimens in a study in Botswana. 25 The lack of association of maternal ART with birth defects seen in our study is consistent with findings from other studies, as well as the Antiretroviral Pregnancy Registry, that confirm the safety of EFV-based ART regimens as used in our cohort of women.…”

Non-linear Relationship of Maternal Age With Risk of Spontaneous Abortion: A Case-Control Study in the China Birth Cohort

“…Studies on the relationship between maternal age and spontaneous abortion have yielded inconsistent results (10)(11)(12). Some studies observed that advanced maternal age was associated with an increased risk of spontaneous abortion (13,14), while others have shown that low maternal age is a risk factor for spontaneous abortion (15,16).…”