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Uterotonic Prophylaxis Trial (UPT)

Primary Purpose

Hemorrhage

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Methergine

placebo

About this trial

This is an interventional prevention trial for Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

SFGH Women's Options Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

methergine

saline placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Amount of Post-procedure Blood Loss Measured in mL

post-procedure blood loss measured in recovery room

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

Number of Participants Who Returned to OR for Re-aspiration During Recovery Period

Returned to OR for re-aspiration

Number of Participants Who Were Admitted for Bleeding After Procedure

hospital admission for bleeding post-procedure

Number of Participants Given Any Uterotonic

any uterotonic medication given intraoperative or postoperative

Secondary Outcome Measures

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

Patients' completed survey regarding side effects in recovery room.

Number of Patients Who Reported Vomiting up to One Hour After Procedure

Patients' completed survey regarding side effects in recovery room.

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

Patients' completed survey regarding side effects in recovery room.

Full Information

NCT ID

NCT02408965

First Posted

March 11, 2015

Last Updated

August 15, 2019

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02408965

Brief Title

Uterotonic Prophylaxis Trial

Acronym

UPT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

284 (Actual)

8. Arms, Groups, and Interventions

Arm Title

methergine

Arm Type

Experimental

Arm Description

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

Arm Title

saline placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Methergine

Other Intervention Name(s)

methylergonovine maleate

Intervention Description

0.2 mg of methylergonovine maleate

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

saline placebo to maintain blinding

Primary Outcome Measure Information:

Title

Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria

Description

Time Frame

Approximately 1-2 hours after procedure

Title

Amount of Post-procedure Blood Loss Measured in mL

Description

post-procedure blood loss measured in recovery room

Time Frame

measured 1 to 2 hours after procedure

Title

Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge

Description

number of participants who had a balloon tamponade placed

Time Frame

duration of procedure and until discharged from hospital

Title

Number of Participants Who Returned to OR for Re-aspiration During Recovery Period

Description

Returned to OR for re-aspiration

Time Frame

from cervical preparation through discharge

Title

Number of Participants Who Were Admitted for Bleeding After Procedure

Description

hospital admission for bleeding post-procedure

Time Frame

post-procedure and during recovery until discharge

Title

Number of Participants Given Any Uterotonic

Description

any uterotonic medication given intraoperative or postoperative

Time Frame

intra-operative or post-operative until discharge

Secondary Outcome Measure Information:

Title

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

Description

Patients' completed survey regarding side effects in recovery room.

Time Frame

Assessed approximately 1 hour after procedure

Title

Number of Patients Who Reported Vomiting up to One Hour After Procedure

Description

Patients' completed survey regarding side effects in recovery room.

Time Frame

Assessed approximately 1 hour after procedure

Title

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

Description

Patients' completed survey regarding side effects in recovery room.

Time Frame

Assessed approximately 1 hour after procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Kerns, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

SFGH Women's Options Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

12. IPD Sharing Statement

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Uterotonic Prophylaxis Trial

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