Uterotonic Prophylaxis Trial (UPT)

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

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 Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Drug: Methergine; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • SFGH Women's Options Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jennifer Kerns, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Methylergonovine
• Other Study ID Numbers: UP Trial 2015