Table 4.
Maternal Obstetrical Outcomes and Adverse Events Potentially Attributable to the Study Intervention.*
| Variable | Magnesium Sulfate (N = 1096) | Placebo (N = 1145) | P Value |
|---|---|---|---|
| Obstetrical outcomes | |||
| Gestational age at delivery — wk | 29.8±3.1 | 29.7±3.1 | 0.32 |
| Receipt of antenatal corticosteroids — no. (%) | 1062 (96.9) | 1116 (97.5) | 0.49 |
| Chorioamnionitis — no./total no. (%) | 127/1086 (11.7) | 131/1141 (11.5) | 0.88 |
| Cesarean delivery — no./total no. (%) | 417/1086 (38.4) | 448/1141 (39.3) | 0.68 |
| Endometritis — no./total no. (%) | 74/1086 (6.8) | 80/1141 (7.0) | 0.85 |
| Pulmonary edema — no./total no. (%) | 8/1086 (0.7) | 3/1141 (0.3) | 0.11 |
| Adverse events† | |||
| Any adverse event — no./total no. (%) | 833/1078 (77.3) | 140/1125 (12.4) | <0.001 |
| Flushing — no./total no. (%) | 703/1078 (65.2) | 74/1125 (6.6) | <0.001 |
| Sweating — no./total no. (%) | 307/1078 (28.5) | 28/1125 (2.5) | <0.001 |
| Pain or burning at intravenous site — no./total no. (%) | 259/1078 (24.0) | 29/1125 (2.6) | <0.001 |
| Nausea or vomiting — no./total no. (%) | 166/1078 (15.4) | 19/1125 (1.7) | <0.001 |
| Respiratory depression — no./total no. (%)‡ | 7/1078 (0.6) | 3/1125 (0.3) | 0.22 |
| Infusion stopped because of adverse event — no./total no. (%) | 45/1078 (4.2) | 16/1125 (1.4) | <0.001 |
*
Plus–minus values are means ±SD. Except for gestational age, which was established systematically by algorithm, data on outcomes are based on clinical diagnoses in the medical records, and data on adverse events are based on notations in the medical records or direct report by the participant to a research nurse.
†
Adverse events are reported only for the mothers who received study medication.
‡
All cases either were self-limited or responded to diuresis and supplemental oxygen.