Uterotonic Prophylaxis Trial
Summary
Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D\&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D\&E at 20 to 24 weeks.
Timeline
- Start
- 2015-03
- Primary completion
- 2017-03
- Completion
- 2017-03
Outcome
Missed primary endpoint
registry analysis (superiority test); Methergine vs Placebo; p = 0.5; Chi-squared NCT02408965 ↗
registry MEAN Methergine: 126 (86 to 166) mL MEAN Placebo: 76 (65 to 88) mL analysis (superiority test); Methergine vs Placebo; p = 0.02; t-test, 2 sided NCT02408965 ↗
registry analysis (superiority test); Methergine vs Placebo; p = 0.04; Chi-squared NCT02408965 ↗
registry analysis (superiority test); Methergine vs Placebo; p = 0.06; Chi-squared NCT02408965 ↗
registry analysis (superiority test); Methergine vs Placebo; p = 0.07; Chi-squared NCT02408965 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylergonovine | Small molecule | 0.2 mg | — |