Uterotonic Prophylaxis Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

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.

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Detailed Description

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Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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methergine

Methergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure

Group Type EXPERIMENTAL

Methergine

Intervention Type DRUG

0.2 mg of methylergonovine maleate

saline placebo

Placebo group saline single injection when manual cervical dilation begins the day before the procedure

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

saline placebo to maintain blinding

Interventions

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Methergine

0.2 mg of methylergonovine maleate

Intervention Type DRUG

placebo

saline placebo to maintain blinding

Intervention Type OTHER

Other Intervention Names

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methylergonovine maleate

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes