Uterotonic Prophylaxis Trial (UPT)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Hemorrhage

Treatments: Drug: Methergine; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02408965

UP Trial 2015

Details and patient eligibility

About

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.

Enrollment: 284 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 2 patient groups, including a placebo group

methergine

Experimental group

Description:

Methergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure

Treatment:

Drug: Methergine

saline placebo

Placebo Comparator group

Description:

Placebo group saline single injection when manual cervical dilation begins the day before the procedure

Treatment:

Other: placebo