Uterotonic Prophylaxis Trial
Completed · Phase 4 · Has a placebo group
Conditions studied: Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT02408965
- Run by
- University of California, San Francisco
- People needed
- 284
- Starts
- 2015-03-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2019-09-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- SFGH Women's Options Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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