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Could a new drug beat the standard for preventing postpartum hemorrhage?

NCT ID NCT06333340

Disease control Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether carbetocin works better than oxytocin to prevent severe bleeding after a planned C-section in women with risk factors like twins, a large baby, or obesity. About 160 participants will receive one of the two drugs, and doctors will measure how many need extra medication to control bleeding. The goal is to find a more effective option for those at higher risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carbetocin and oxytocin
What this could lead to
If carbetocin works better, it could reduce dangerous bleeding after C-sections in high-risk women.
What could go wrong
This is a small, early-phase trial (160 participants) and may not prove carbetocin is superior. Both drugs have known side effects like nausea or low blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria - Any one or more of the risk factors for uterine atony: * Overdistended uterus due to: * Polyhydramnios (amniotic fluid index \>24 cm) * Fetal macrosomia reported on prenatal ultrasound \>90th centile or \> 4000 gm * Multiple gestation * History of uterine atony/PPH (documented with blood loss of \>1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization) * Obesity with body mass index (BMI) \>40 kg/m2 * Diabetes mellitus on treatment * Preeclampsia on treatment * Placenta previa Exclusion criteria: * Valvular heart disease, arrhythmias, or heart failure * Placenta accreta spectrum * Bleeding disorder * Anemia (\<100 g/dl) * Allergy or sensitivity to oxytocin or carbetocin

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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post partum hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G1X5, Canada

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