Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage

NCT ID: NCT05245227

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2027-01-01

Brief Summary

To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage.

There have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage.

Specific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage.

Specific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).

Detailed Description

Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality in the world, accounting for a quarter of all maternal deaths globally. Most cases of PPH can be attributed to uterine atony, failure of the uterus to contract in the immediate postpartum period. Efforts to prevent uterine atony and thereby PPH have focused on active clinical management of the third stage of labor (the period between delivery of the infant and placenta) and the administration of uterotonic agents (medication that induces uterine contraction). Universal standard of care to prevent postpartum hemorrhage, according to the American College of Obstetrics and Gynecologists and World Health Organization includes various dose infusions of oxytocin. Additional uterotonics are given if necessary, according to noted blood loss and uterine tone. The best uterotonic(s), combination, route, and dose, however, remain actively debated. Randomized controlled trials have not proven that misoprostol is superior to oxytocin or methergine to treat postpartum hemorrhage, but it is a medication that is often used conjunctively or after other agents fail. A Cochrane review of treatment of primary postpartum hemorrhage revealed that oxytocin, ergot alkaloids (i.e., methergine), and combined oxytocin-ergot alkaloid administration were equally effective in preventing PPH in the general obstetric population, whereas prostaglandins alone (i.e., misoprostol) were not. In an effort to determine the benefit of a simultaneous double uterotonic agent regimen in the prevention of PPH, the investigators propose to conduct a controlled trial in which women will be randomly assigned to an intervention group (buccal misoprostol and intravenous oxytocin administered simultaneously) versus a control group (standard of care, intravenous oxytocin alone).

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intravenous Oxytocin only

Patients will receive standard postpartum Oxytocin IV per protocol

Group Type: ACTIVE_COMPARATOR

IV Oxytocin

Intervention Type: DRUG

40 units IV Oxytocin in 1000 mL normal saline

Misoprostol plus intravenous Oxytocin

Patients will receive standard postpartum Oxytocin IV per protocol and also be given Misoprostol 400 mcg sublingual

Group Type: EXPERIMENTAL

Sublingual Misoprostol

Intervention Type: DRUG

Misoprostol 400 mcg sublingual

IV Oxytocin

Intervention Type: DRUG

40 units IV Oxytocin in 1000 mL normal saline

Interventions

Sublingual Misoprostol

Misoprostol 400 mcg sublingual

Intervention Type: DRUG

IV Oxytocin

40 units IV Oxytocin in 1000 mL normal saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study

Exclusion Criteria

• Women under 18 years old
• Women with known coagulation disorders
• Women with planned cesarean hysterectomy
• Women with known placental accreta spectrum disorders
• Women with known allergy to prostaglandins

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

James Bernasko

MD, Professor, Clinical Obstetrics, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stony Brook University

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Erin Cassella

Role: primary

erin.casella@stonybrookmedicine.edu

631-444-7650

Other Identifiers

IRB2021-00142

Identifier Type: -

Identifier Source: org_study_id