Uterotonic Prophylaxis Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion

Conditions
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Hemorrhage

Intervention / Treatment
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* Drug: Methergine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methergine<br>Methergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure | Drug: Methergine<br>* 0.2 mg of methylergonovine maleate<br>* Other names: methylergonovine maleate;|
| Placebo Comparator: saline placebo<br>Placebo group saline single injection when manual cervical dilation begins the day before the procedure | Other: placebo<br>* saline placebo to maintain blinding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria | 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 | Approximately 1-2 hours after procedure | 
| Amount of Post-procedure Blood Loss Measured in mL | post-procedure blood loss measured in recovery room | measured 1 to 2 hours after procedure | 
| Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge | number of participants who had a balloon tamponade placed | duration of procedure and until discharged from hospital | 
| Number of Participants Who Returned to OR for Re-aspiration During Recovery Period | Returned to OR for re-aspiration | from cervical preparation through discharge | 
| Number of Participants Who Were Admitted for Bleeding After Procedure | hospital admission for bleeding post-procedure | post-procedure and during recovery until discharge | 
| Number of Participants Given Any Uterotonic | any uterotonic medication given intraoperative or postoperative | intra-operative or post-operative until discharge | 

Secondary Outcome Measures

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