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Uterotonic Prophylaxis Trial (UPT)

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ClinicalTrials.gov Identifier: NCT02408965
Recruitment Status : Completed
First Posted : April 6, 2015
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemorrhage Drug: Methergine Other: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408965


Locations
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United States, California
SFGH Women's Options Center
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jennifer Kerns, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol  [PDF] April 10, 2014
Statistical Analysis Plan  [PDF] April 10, 2014

More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02408965    
Other Study ID Numbers: UP Trial 2015
First Posted: April 6, 2015    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Methylergonovine
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs