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Could a single drug replace the standard cocktail for C-Section bleeding?

NCT ID NCT07636421

Disease control Sponsor: Mansoura University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways to prevent heavy bleeding after a planned C-section: one drug (carbetocin) alone versus the same drug plus a slow drip of another (oxytocin). About 332 women having planned C-sections will take part. The goal is to see if the single drug works just as well, which could simplify care and reduce side effects.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 332 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Adult women aged 18 to 45 years * Scheduled for elective non-emergency cesarean delivery * Spinal anesthesia planned and administered as the sole anesthetic technique * Singleton pregnancy at gestational age of 37 completed weeks or more * ASA physical status II * Preoperative hemoglobin of 9 g/dL or more * Able to provide written informed consent in Arabic or English Exclusion Criteria: * Emergency or crash cesarean delivery * Placenta previa, placenta accreta spectrum disorder, or other abnormal placentation * Known uterine anomalies likely to impair contractility including fibroids greater than 5 cm, bicornuate or unicornuate uterus * Grand multiparity defined as 5 or more previous deliveries * Multiple gestation including twins or higher order * Polyhydramnios defined as amniotic fluid index greater than 24 cm * Prior oxytocin augmentation in current pregnancy for more than 6 hours * Known hypersensitivity to carbetocin, oxytocin, or any formulation excipient * Severe preeclampsia, eclampsia, or HELLP syndrome * Cardiovascular disease including arrhythmia, valvular disease, cardiomyopathy, or ischemic heart disease * Known coagulopathy or thrombocytopenia with platelets less than 100 x 10\^9/L * Hepatic or renal impairment * Body mass index greater than 40 kg/m2 at time of delivery * Enrollment in another interventional clinical trial

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Postpartum Hemorrhage Uterine Inertia

As listed by the trial registrant

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

Blood loss, surgical Cesarean section Postpartum hemorrhage Uterine atony

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

  • Qassim University Medical City

    Buraidah, Al-Qassim Region, 51452, Saudi Arabia

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