drugset / Trial / NCT02408965

Uterotonic Prophylaxis Trial

NCT02408965

Phase 4 Completed 284 enrolled University of California, San Francisco
RandomizedParallel-groupQuadruple-blindPrevention

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylergonovine Small molecule 0.2 mg

Indications