Uterotonic Prophylaxis Trial

Hemorrhage Clinical Trial

— UPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408965
• Other study ID #: UP Trial 2015
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• Methergine
0.2 mg of methylergonovine maleate

Other:
• placebo
saline placebo to maintain blinding

Locations

Country	Name	City	State
United States	SFGH Women's Options Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Amount of Post-procedure Blood Loss Measured in mL	post-procedure blood loss measured in recovery room	measured 1 to 2 hours after procedure
Primary	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
Primary	Number of Participants Who Returned to OR for Re-aspiration During Recovery Period	Returned to OR for re-aspiration	from cervical preparation through discharge
Primary	Number of Participants Who Were Admitted for Bleeding After Procedure	hospital admission for bleeding post-procedure	post-procedure and during recovery until discharge
Primary	Number of Participants Given Any Uterotonic	any uterotonic medication given intraoperative or postoperative	intra-operative or post-operative until discharge
Secondary	Number of Participants Who Reported Nausea up to One Hour After Procedure	Patients' completed survey regarding side effects in recovery room.	Assessed approximately 1 hour after procedure
Secondary	Number of Patients Who Reported Vomiting up to One Hour After Procedure	Patients' completed survey regarding side effects in recovery room.	Assessed approximately 1 hour after procedure
Secondary	Number of Participants Who Reported Cramping up to One Hour After Procedure	Patients' completed survey regarding side effects in recovery room.	Assessed approximately 1 hour after procedure