Table 3.
Maternal and neonatal outcomes by treatment assignment
| 17P (n=399) | Placebo (n=401) | Risk difference (95% CI) | Relative risk (95% CI) | |
|---|---|---|---|---|
| Maternal outcomes | ||||
| Pregnancy-induced hypertension | 13 (3%) | 6 (2%) | 1·8% (−0·3 to 3·9) | 2·2 (0·8 to 5·7) |
| Pre-eclampsia | 6 (2%) | 9 (2%) | −0·7% (−2·6 to 1·1) | 0·7 (0·2 to 1·9) |
| Eclampsia | 0 (0%) | 1 (<1%) | .. | .. |
| Maternal death | 0 (0%) | 1 (<1%) | .. | .. |
| Antepartum haemorrhage | 6 (2%) | 7 (2%) | −0·2% (−2·0 to 1·5) | 0·9 (0·3 to 2·5) |
| Preterm prelabour rupture of membranes | 5 (1%) | 7 (2%) | −0·5% (−2·2 to 1·2) | 0·7 (0·2 to 2·2) |
| Oligohydramnios | 2 (1%) | 2 (1%) | .. | .. |
| Polyhydramnios | 22 (6%) | 19 (5%) | 0·8% (−2·3 to 3·8) | 1·2 (0·6 to 2·1) |
| Chorioamnionitis | 1 (<1%) | 0 (0%) | .. | .. |
| Caesarean delivery | 73 (18%) | 77 (19%) | −0·9% (−6·3 to 4·5) | 1·0 (0·7 to 1·3) |
| Neonatal outcomes | ||||
| Birthweight <10th percentile for gestational age* | 95/392 (24%) | 93/394 (24%) | 0·6% (−5·3 to 6·6) | 1·0 (0·8 to 1·3) |
| Birthweight <3rd percentile for gestational age* | 28/392 (7%) | 47/394 (12%) | −4·8% (−8·9 to −0·7) | 0·6 (0·4 to 0·9) |
| Birthweight <2500 g† | 41/395 (10%) | 46/395 (12%) | −1·3% (−5·6 to 3·1) | 0·9 (0·6 to 1·3) |
| Birthweight <1500 g† | 7/395 (2%) | 7/395 (2%) | 0·0% (−1·8 to 1·8) | 1·0 (0·4 to 2·8) |
| 1-min Apgar score <7 among liveborn infants‡ | 12/336 (4%) | 9/338 (3%) | 0·9% (−1·7 to 3·5) | 1·3 (0·6 to 3·1) |
| 5-min Apgar score <7 among liveborn infants§ | 7/137 (5%) | 2/144 (1%) | .. | .. |
| Neonatal intensive care unit admission among liveborn infants¶ | 29/389 (7%) | 24/390 (6%) | 1·3% (−2·2 to 4·8) | 1·2 (0·7 to 2·0) |
| Neonatal supplemental oxygen requirement among liveborn infants¶ | 13/389 (3%) | 10/390 (3%) | 0·8% (−1·6 to 3·2) | 1·3 (0·6 to 2·9) |
| Neonatal assisted ventilation among liveborn infants¶ | 1/389 (<1%) | 1/390 (<1%) | .. | .. |
| Neonatal death‖ | 14/388 (4%) | 7/386 (2%) | 1·8% (−0·5 to 4·1) | 2·0 (0·8 to 4·9) |
| Infant HIV infection** | 1/374 (<1%) | 1/379 (<1%) | .. | .. |
Data are n (%) or n/N (%) unless otherwise specified. Statistical tests were not done when there were fewer than five events in either group. 17P=17 alpha-hydroxyprogesterone caproate.
Birthweight not recorded for 10 neonates and birthweight centile not able to be calculated for another 4 neonates.
Birthweight not recorded for 10 neonates.
21 stillborn infants excluded and 1-minute Apgar not recorded for 105 liveborn infants.
21 stillborn infants excluded and 5-minute Apgar score not recorded for 498 liveborn infants.
21 stillborn infants excluded.
21 stillborn infants excluded and 5 infants with undocumented vital status at 28 days of life.
21 stillborn infants and 21 neonatal deaths excluded. 5 infants did not return for HIV testing at 6 weeks of life.