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

ConditionPostpartum Hemorrhage

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18+

SponsorStony Brook University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Women under 18 years old

Women with known coagulation disorders

Women with planned cesarean hysterectomy

Women with known placental accreta spectrum disorders

Trial design

Design model

Parallel

Treatments tested in this trial

Sublingual Misoprostol
Drug
Misoprostol 400 mcg sublingual
IV Oxytocin
Drug
40 units IV Oxytocin in 1000 mL normal saline

Treatment groups

1,358 Participants

are divided into 2 treatment groups

Group A: Intravenous Oxytocin onlyActive comparator 1 intervention

Group B: Misoprostol plus intravenous OxytocinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

through study completion, an average of 1 year

Secondary outcomes

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.

Determine any potential side effects of a double simultaneous uterotonic agent regimen (misoprostol and oxytocin) versus a single agent (oxytocin only).

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stony Brook University

Lead sponsor

Source ClinicalTrials.gov

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