Table 3. Maternal Outcomes (Intention-to-Treat Analysis)a.
| Outcome | No./total No. (%) | RR (95% CI) | Mean difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Sildenafil | Placebo | ||||
| Treatment duration, mean (SD), d | 24/108 (18) | 20/107 (43) | NA | 3.73 (−5.44 to 12.91) | .43 |
| Gestational age at birth, mean (SD), wk | 29 3/7 (4 0/7) | 29 3/7 (4 3/7) | NA | −0.01 (−1.12 to 1.11) | .99 |
| Preterm birth, wk | |||||
| <28 | 46/108 (42.6) | 48/107 (44.9) | 0.95 (0.70 to 1.29) | NA | .74 |
| <37 | 97/108 (89.8) | 90/107 (84.1) | 1.07 (0.96 to 1.18) | NA | .22 |
| Pregnancy prolongation after randomization, mean (SD), d | 34 (28) | 33 (32) | NA | 0.64 (−7.4 to 8.67) | .88 |
| Mode of delivery | .46 | ||||
| Cesarean | NA | ||||
| On fetal indication | 57/108 (52.8) | 51/107 (47.7) | NA | NA | |
| On maternal indication | 14/108 (13.0) | 14/107 (13.1) | NA | NA | |
| Induced vaginal birth | |||||
| On fetal indication | 7/108 (6.5) | 12/107 (11.2) | NA | NA | |
| On maternal indication | 8/108 (7.4) | 3/107 (2.8) | NA | NA | |
| Spontaneous vaginal birth | 9/108 (8.3) | 11/107 (10.3) | NA | NA | |
| Induction of labor after intrauterine death | 12/108 (11.1) | 16/107 (15.0) | NA | NA | |
| Pregnancy hypertension | 74/108 (68.5) | 72/107 (67.3) | 1.02 (0.85 to 1.22) | NA | .85 |
| Pre-eclampsia | 42/108 (38.9) | 44/107 (41.1) | 0.95 (0.68 to 1.31) | NA | .74 |
| HELLP syndrome | 12/108 (11.1) | 10/107 (9.3) | 1.19 (0.54 to 2.63) | NA | .67 |
| Maternal use of antihypertensive treatment antenatal or postnatal, No. used | |||||
| None | 50/108 (46.3) | 53/107 (49.5) | NA | NA | .61 |
| 1 | 32/108 (29.6) | 34/107 (31.8) | NA | NA | |
| 2 | 16/108 (14.8) | 15/107 (14.0) | NA | NA | |
| ≥3 | 10/108 (9.3) | 5/107 (4.7) | NA | NA | |
| Maternal magnesium sulphate for hypertension | 14/108 (13.0) | 15/107 (14.0) | 0.92 (0.47 to 1.82) | NA | .82 |
| Antenatal corticosteroids for fetal lung maturation before birth | |||||
| 48 h to 14 d (complete course) | 52/85 (61.2) | 56/78 (71.8) | 0.85 (0.68 to 1.06) | NA | .15 |
| <48 h (incomplete course) | 4/85 (4.8) | 7/78 (9.0) | 0.52 (0.16 to 1.72) | NA | .29 |
Abbreviation: NA, not applicable; HELLP, hemolysis, elevated liver enzymes, and low platelets; RR, relative risk.
a
Intention-to-treat analysis corrected for gestational age and estimated fetal weight at randomization. Per-protocol analysis had similar results.