Phase 4 N=284 Randomized Quadruple-blind Prevention

Uterotonic Prophylaxis Trial

Hemorrhage

Bottom Line

View on ClinicalTrials.gov: NCT02408965 ↗

Enrolled (actual)

284

Serious AEs

1.4%

Results posted

Sep 2019

Primary outcome: Primary: Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria — 78; 75 Participants — p=0.5

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Methergine (Drug); placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Francisco
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria	78; 75	0.5
PRIMARY Amount of Post-procedure Blood Loss Measured in mL	126; 76	0.02 sig
PRIMARY Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge	20; 10	0.04 sig
PRIMARY Number of Participants Who Returned to OR for Re-aspiration During Recovery Period	4; 0	0.06
PRIMARY Number of Participants Who Were Admitted for Bleeding After Procedure	4; 0	0.06
PRIMARY Number of Participants Given Any Uterotonic	56; 43	0.07
SECONDARY Number of Participants Who Reported Nausea up to One Hour After Procedure	42; 18	<0.001 sig
SECONDARY Number of Patients Who Reported Vomiting up to One Hour After Procedure	18; 8	0.03 sig
SECONDARY Number of Participants Who Reported Cramping up to One Hour After Procedure	100; 84	0.02 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02408965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.