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A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion (UPT)
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.
Details
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 284 |
| Start date | 2015-03 |
| Completion | 2017-03 |
Conditions
- Hemorrhage
Interventions
- Methergine
- placebo
Primary outcomes
- Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria — Approximately 1-2 hours after procedure
Clinical factors included in composite outcome of excessive bleeding after D\&E: Post-procedure total blood loss \> 125cc (after D\&E) Transfusion Admission for bleeding Re-aspiration for bleeding Balloon tamponade Uterine artery embolization Major surgery for bleeding At least 1 uterotonic medication given Prescription given for any uterotonic medication at discharge Uterine compression (uterine massage or manual pressure for 2 minutes - Amount of Post-procedure Blood Loss Measured in mL — measured 1 to 2 hours after procedure
post-procedure blood loss measured in recovery room - Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge — duration of procedure and until discharged from hospital
number of participants who had a balloon tamponade placed - Number of Participants Who Returned to OR for Re-aspiration During Recovery Period — from cervical preparation through discharge
Returned to OR for re-aspiration - Number of Participants Who Were Admitted for Bleeding After Procedure — post-procedure and during recovery until discharge
hospital admission for bleeding post-procedure - Number of Participants Given Any Uterotonic — intra-operative or post-operative until discharge
any uterotonic medication given intraoperative or postoperative
Countries
United States