Clinical trial NCT02408965: Uterotonic Prophylaxis Trial
Official title: A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-04-06
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria
timeFrame: Approximately 1-2 hours after procedure
measure: Amount of Post-procedure Blood Loss Measured in mL
timeFrame: measured 1 to 2 hours after procedure
measure: Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge
timeFrame: duration of procedure and until discharged from hospital
measure: Number of Participants Who Returned to OR for Re-aspiration During Recovery Period
timeFrame: from cervical preparation through discharge
measure: Number of Participants Who Were Admitted for Bleeding After Procedure
timeFrame: post-procedure and during recovery until discharge
measure: Number of Participants Given Any Uterotonic
timeFrame: intra-operative or post-operative until discharge
Secondary outcomes:
measure: Number of Participants Who Reported Nausea up to One Hour After Procedure
timeFrame: Assessed approximately 1 hour after procedure
measure: Number of Patients Who Reported Vomiting up to One Hour After Procedure
timeFrame: Assessed approximately 1 hour after procedure
measure: Number of Participants Who Reported Cramping up to One Hour After Procedure
timeFrame: Assessed approximately 1 hour after procedure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SFGH Women's Options Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennifer Kerns, MD
role: PRINCIPAL_INVESTIGATOR
References: