NCT05245227

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,358

participants targeted

Target at P75+ for phase_3

Timeline
6mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Jan 2025Jan 2027

First Submitted

Initial submission to the registry

November 18, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

November 18, 2021

Last Update Submit

April 30, 2025

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage blood loss volume.

    Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in changing postpartum hemorrhage.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Determine serious adverse outcomes of a double simultaneous uterotonic agent regimen (misoprostol and oxytocin) versus a single agent (oxytocin only) that is documented in the medical record.

    through study completion, an average of 1 year

Study Arms (2)

Intravenous Oxytocin only

ACTIVE COMPARATOR

Patients will receive standard postpartum Oxytocin IV per protocol

Drug: IV Oxytocin

Misoprostol plus intravenous Oxytocin

EXPERIMENTAL

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

Drug: Sublingual MisoprostolDrug: IV Oxytocin

Interventions

Sublingual MisoprostolDRUG

Misoprostol 400 mcg sublingual

Misoprostol plus intravenous Oxytocin
IV OxytocinDRUG

40 units IV Oxytocin in 1000 mL normal saline

Intravenous Oxytocin onlyMisoprostol plus intravenous Oxytocin

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients will be female postpartum patients
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor, Clinical Obstetrics, Principal investigator

Study Record Dates

First Submitted

November 18, 2021

First Posted

February 17, 2022

Study Start

January 27, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations

US(1)