Uterotonic Prophylaxis Trial

NCT02408965 | Completed Phase 4 Results DMC

• 1 other identifier: UP Trial 2015
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

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

  Assessed approximately 1 hour after procedure

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

  Assessed approximately 1 hour after procedure

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

  Assessed approximately 1 hour after procedure

Study Arms (2)

methergine

EXPERIMENTAL

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

Drug: Methergine

saline placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

Methergine DRUG

0.2 mg of methylergonovine maleate

Also known as: methylergonovine maleate

methergine

placebo OTHER

saline placebo to maintain blinding

saline placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 20 wks 0 days gestation and 24 wks 0 days gestation
• English or Spanish speaking
• BP before injection 140/90 or below
• years old or over

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

SFGH Women's Options Center

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Methylergonovine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ergonovine; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Designed our study using a one-sided hypothesis given our belief that methergine could not cause increased bleeding based on postpartum data.

Results Point of Contact

• Title: Jennifer Kerns
• Organization: UCSF

Jennifer.kerns@ucsf.edu

4152068715

Study Officials

• Jennifer Kerns, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: April 6, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

US (1)