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Completed

NCT Number: NCT02408965

Uterotonic Prophylaxis Trial

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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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

SFGH Women's Options Center

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methergine

Drug

0.2 mg of methylergonovine maleate

Other names: methylergonovine maleate

Placebo

Other

saline placebo to maintain blinding

Primary outcomes

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

    Time frame: Approximately 1-2 hours after procedure

    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

  2. Amount of Post-procedure Blood Loss Measured in mL

    Time frame: measured 1 to 2 hours after procedure

    post-procedure blood loss measured in recovery room

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

    Time frame: duration of procedure and until discharged from hospital

    number of participants who had a balloon tamponade placed

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

    Time frame: from cervical preparation through discharge

    Returned to OR for re-aspiration

  5. Number of Participants Who Were Admitted for Bleeding After Procedure

    Time frame: post-procedure and during recovery until discharge

    hospital admission for bleeding post-procedure

  6. Number of Participants Given Any Uterotonic

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

    any uterotonic medication given intraoperative or postoperative

Secondary outcomes

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

    Time frame: Assessed approximately 1 hour after procedure

    Patients' completed survey regarding side effects in recovery room.

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

    Time frame: Assessed approximately 1 hour after procedure

    Patients' completed survey regarding side effects in recovery room.

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

    Time frame: Assessed approximately 1 hour after procedure

    Patients' completed survey regarding side effects in recovery room.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: UPT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2015
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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