TABLE 2.
Labor and delivery outcomes of women in IMPROVE study
| N = 152, 24 censored | N = 148, 34 censored | Pvaluea | HR [95% CI]a | Pvaluenoninferiority | |
|---|---|---|---|---|---|
| Time to delivery (hours), median [95% CI] | 20.1 [18.2, 22.8] | 28.1 [24.1, 31.4] | .006 | 0.70 [0.54, 0.90] | .663 |
| VM group (n = 152) | BM group (n = 148) | Pvalueb | |
|---|---|---|---|
| Cesarean for fetal nonreassurance, n (%) | 5 (3.3) | 14 (9.5) | .033 |
| Vaginal delivery in less than 24 hours, n (%) | 89 (58.6) | 58 (39.2) | .001 |
| Reason for stopping misoprostol, n (%) | .006d | ||
| Onset of active labor | 7 (4.6) | 10 (6.8) | |
| Sufficient cervical ripening | 60 (39.5) | 43 (29.1) | |
| Safety concerns | 47 (30.9) | 34 (23) | |
| Multiple reasons | 31 (20.4) | 38 (25.7) | |
| Other | 7 (4.6) | 23 (15.5) | |
| Route of delivery, n (%) | .151 | ||
| Vaginal delivery | 127c (84.2) | 115 (77.7) | |
| Cesarean delivery | 24 (15.8) | 33 (22.3) | |
| Cesarean (indications), n (%) | N = 24 | N = 33 | .376d |
| Fetal nonreassurance | 5 (20.8) | 14 (42.4) | |
| Arrest of dilation | 3 (12.5) | 4 (12.1) | |
| Arrest of descent | 3 (12.5) | 1 (3.0) | |
| Multiple reasons | 11 (45.8) | 11 (33.3) | |
| Other | 2 (8.3) | 3 (9.1) | |
| Chorioamnionitis, n (%) | 7 (4.6) | 10 (6.8) | .420d |
| Postpartum hemorrhage, n (%) | 8 (5.3) | 6 (4.0) | .620d |
| Blood transfusion, n (%) | 1 (0.6) | 1 (0.7) | .794d |
| Oxytocin use, n (%) | 100 (65.8) | 111 (75) | .081 |
| Doses of misoprostol needed to get into active labor (n), median (range) | 2.0 (1.0–5.0) | 3.0 (1.0–7.0) | <.001d |
| Maximum units of oxytocin administered, median (range) | 4.0 (0–36.0) | 6.0 (0–30.0) | .001d |
P value for noninferiority hypothesis based on Cox proportional hazards model (H0: HR ≤ 0.74 vs HA: HR > 0.74); P value < .05 provides evidence to reject inferiority and conclude BM is noninferior to VM.
BM, buccal misoprostol; CI, confidence interval; HR, hazard ratio; VM, vaginal misoprostol.
P value from log-rank tests; profile likelihood confidence intervals reported for 95% CI of HR;
P values obtained from t test (continuous) or χ2 test (categorical);
One subject was admitted into the study, got discharged, and then returned 2 weeks later to have a vaginal delivery. Delivery characteristics (except for route of delivery) are included for this person as they were censored for time to delivery;
P values obtained from Wilcoxon rank sum test (continuous) or Fisher exact test (categorical).