NCT02408965

Uterotonic Prophylaxis Trial

A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hemorrhage

Interventions

Type	Name	Description
DRUG	Methergine	0.2 mg of methylergonovine maleate
OTHER	placebo	saline placebo to maintain blinding

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-04-06
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

1 site across 1 country: United States