A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 284
- Locations
- 1
- Primary Endpoint
- Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
methergine
Methergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure
Intervention: Methergine (Drug)
saline placebo
Placebo group saline single injection when manual cervical dilation begins the day before the procedure
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: from cervical preparation through discharge
Returned to OR for re-aspiration
Number of Participants Who Were Admitted for Bleeding After Procedure
Time Frame: post-procedure and during recovery until discharge
hospital admission for bleeding post-procedure
Number of Participants Given Any Uterotonic
Time Frame: intra-operative or post-operative until discharge
any uterotonic medication given intraoperative or postoperative
Secondary Outcomes
- Number of Participants Who Reported Nausea up to One Hour After Procedure(Assessed approximately 1 hour after procedure)
- Number of Patients Who Reported Vomiting up to One Hour After Procedure(Assessed approximately 1 hour after procedure)
- Number of Participants Who Reported Cramping up to One Hour After Procedure(Assessed approximately 1 hour after procedure)