Uterotonic Prophylaxis Trial

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
saline placebo	placebo	Placebo group saline single injection when manual cervical dilation begins the day before the procedure
methergine	Methergine	Methergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Cramping up to One Hour After Procedure	Assessed approximately 1 hour after procedure	Patients' completed survey regarding side effects in recovery room.
Number of Participants Who Reported Nausea up to One Hour After Procedure	Assessed approximately 1 hour after procedure	Patients' completed survey regarding side effects in recovery room.
Number of Patients Who Reported Vomiting up to One Hour After Procedure	Assessed approximately 1 hour after procedure	Patients' completed survey regarding side effects in recovery room.