Table 2.
Fetal and neonatal death.
| Meisa | PROLONGb | Integrated | ||||
|---|---|---|---|---|---|---|
| 17P n/N (%) | Placebo n/N (%) | 17P n/N (%) | Placebo n/N (%) | 17P n/N (%) | Placebo n/N (%) | |
| Miscarriagec | 5/209 (2.4) | 0/107 (0) | 4/866 (0.5) | 7/448 (1.6) | 9/1075 (0.8) | 7/555 (1.3) |
| RR (95% CI) | NC | 0.28 (0.08–0.94) | 0.66 (0.25–1.78) | |||
| Stillbirth d | 6/301 (2.0) | 2/153 (1.3) | 12/1124 (1.1) | 3/571 (0.5) | 18/1425 (1.3) | 5/724 (0.7) |
| RR (95% CI) | 1.56 (0.31–7.80) | 2.07 (0.59–7.29) | 1.83 (0.68–4.91) | |||
| Neonatal deathe | 8/295 (2.7) | 9/151 (6.0) | 6/1093 (0.5) | 3/559 (0.5) | 14/1388 (1.0) | 12/710 (1.7) |
| RR (95% CI) | 0.44 (0.17–1.13) | 0.98 (0.24–3.91) | 0.60 (0.28–1.28) | |||
| Fetal/neonatal deathf | 19/310 (6.1) | 11/153 (7.2) | 22/1128 (2.0) | 13/578 (2.3) | 41/1438 (2.9) | 24/731 (3.3) |
| RR (95% CI) | 0.85 (0.42–1.75) | 0.85 (0.43–1.67) | 0.86 (0.53–1.41) | |||
Relative risk is unadjusted for Meis, adjusted for gestational age at randomization stratum in PROLONG and adjusted for study in the integrated analysis.
NA not applicable, NC not calculable, RR relative risk, 17P 17-α-hydroxyprogesterone caproate, CI confidence interval.
bReference [10].
cDenominator is number of subjects who received study drug and were randomized 200/7weeks of GA. Miscarriage was defined as spontaneous delivery from 160/7 to 196/7 weeks of gestation.
dDenominator is number of subjects who received study drug and were pregnant beyond ≥200/7 weeks of GA. Stillbirth was defined as antepartum or intrapartum death from 200/7 weeks of gestation through term.
eDenominator is number of subjects who received study drug and did not have a miscarriage or stillbirth. Patients with missing data are assumed not to have the specified outcome.
fDenominator is number of patients who received study drug.