Table 3.

Adverse Birth Outcomes in Deliveries among Women with Exposure to Dolutegravir or Efavirenz from Conception, October 2016–March 2019.^*

Adverse Birth Outcome	DTG from Conception (N = 1271)	EFV from Conception (N = 4430)	Adjusted Relative Risk (95% CI)†
	number/total number (percent)
Any adverse birth outcome	422/1271 (33.2)	1550/4430 (35.0)	0.94 (0.86–1.02)
Any severe birth outcome	151/1271 (11.9)	568/4430 (12.8)	0.89 (0.74–1.05)
Preterm birth‡	237/1254 (18.9)	841/4369 (19.2)	1.01 (0.89–1.15)
Very preterm birth§	58/1254 (4.6)	215/4369 (4.9)	0.91 (0.68–1.23)
Small for gestational age¶	211/1244 (17.0)	787/4328 (18.2)	0.87 (0.75–1.00)
Very small for gestational age‖	81/1244 (6.5)	315/4328 (7.3)	0.82 (0.64–1.04)
Stillbirth	33/1271 (2.6)	89/4429 (2.0)	1.36 (0.91–2.04)
Neonatal death in hospital	14/1232 (1.1)	71/4334 (1.6)	0.71 (0.39–1.28)

^*Comparisons included singleton pregnancies with continuous exposure to dolutegravir-based or efavirenz-based ART from the time of conception and in which infants were born at one of the eight original sites since October 1, 2016, when the first exposure to dolutegravir from conception occurred.

^†All models were adjusted for maternal age, gravida, and educational attainment. These variables were chosen a priori and added to the model simultaneously.

^‡Preterm birth was defined as birth before 37 weeks of gestation.

^§Very preterm birth was defined as birth before 32 weeks of gestation.

^¶Small for gestational age was defined as a body weight lower than the 10th percentile for gestational age.

^‖Very small for gestational age was defined as a body weight lower than the 3rd percentile for gestational age.