Uterotonic Prophylaxis Trial

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Methylergonovine

Criteria

Inclusion Criteria:

• Between 20 wks 0 days gestation and 24 wks 0 days gestation

• English or Spanish speaking

• BP before injection 140/90 or below

• 18 years old or over

Exclusion criteria:

• hypertension either on the preoperative or operative day (defined as systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg)

• D&E procedures with more than one day of cervical preparation with dilators

• use of protease inhibitors

• known coagulopathy

• known morbidly adherent placenta