Uterotonic Prophylaxis Trial

University of California, San Francisco284 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

284

Conditions

Hemorrhage

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Approximately 1-2 hours after procedure

Amount of Post-procedure Blood Loss Measured in mL

post-procedure blood loss measured in recovery room

Time frame: 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

Time frame: 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

Time frame: from cervical preparation through discharge

Number of Participants Who Were Admitted for Bleeding After Procedure

hospital admission for bleeding post-procedure

Time frame: post-procedure and during recovery until discharge

Number of Participants Given Any Uterotonic

any uterotonic medication given intraoperative or postoperative

Time frame: intra-operative or post-operative until discharge

Secondary Outcomes

Number of Participants Who Reported Nausea up to One Hour After Procedure

Patients' completed survey regarding side effects in recovery room.

Time frame: 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.

Time frame: 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.

Time frame: Assessed approximately 1 hour after procedure

Uterotonic Prophylaxis Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes