Table 5.

Fetal/neonatal health complications by treatment arm and eligibility strata among women with clinical pregnancies: the Effects of Aspirin in Gestation and Reproduction trial.

	Total=728
Fetal/neonatal health complication	LDA N=372.7 n (%)	Placebo N=358.9 n (%)	RD	95% CI	P
Fetal death (>20 weeks)*	1 (0)	2 (1)	−0.3	−1.2 – 0.7	0.57
Neonatal death†	2 (1)	1 (0)	0.3	−0.7 – 1.0	0.71
Infant received specialized care‡	25 (7)	32 (9)	−2.3	−6.3 – 1.8	0.25
Intracranial hemorrhage§	0 (0)	0d (0)	NA	NA	NA
Pulmonary hypertension‖	1 (0)	0 (0)	0.3	NA	0.32

Abbreviation: RD, risk difference; CI, confidence interval; NA, not applicable

P-value calculated using Chi-squared test. Inverse probability of conception weights were applied to control for selection bias introduced by stratifying on pregnancy status.

^*The fetal death in the LDA group was due to a cord accident. In the placebo group one fetal death was diagnosed with trisomy 18 and the other cause of fetal death was unknown.

^†Neonatal deaths were only captured if the neonate died before hospital discharge or before the mother completed her postpartum interview (approximately 6–8 weeks postpartum). The two neonatal deaths in the LDA group were in severely premature infants and the one death in the placebo group was due to uterine rupture following a motor vehicle accident.

^‡Infant care included neonatal intensive care unit (NICU), special care unit, intermediate care, or step down unit.

^§One infant in the placebo group was diagnosed with a left cerebral infarction in utero. No information was available regarding whether intracranial hemorrhage preceded the infarction.

^‖Pulmonary hypertension was reported by the mother during the postpartum interview. Delivery record was not available for abstraction for confirmation.