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Which drug is safer for the heart after delivery? new study investigates

NCT ID NCT03899961

Knowledge-focused Sponsor: Oslo University Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study compared the heart effects of two drugs, oxytocin and carbetocin, given to prevent bleeding after childbirth. Researchers measured a heart injury marker (troponin I) in 240 healthy pregnant women after delivery. The goal was to see if carbetocin might be less harmful to the heart than oxytocin, which could help guide treatment choices for women with heart conditions.

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 (drugs given after childbirth to prevent bleeding)
What this could lead to
If carbetocin is shown to be safer for the heart, it could become the preferred drug for preventing bleeding after delivery, especially in women with heart conditions.
What could go wrong
This is a completed Phase 4 trial, but it only looked at a marker of heart injury (troponin I) in healthy women, not actual heart problems or long-term outcomes. The results may not apply to women with heart disease.

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

240 people

The number who actually took part.

Started

Apr 2019

Finished

Apr 2022

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

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: 1. Healthy pregnant women age 18 to 50 2. Singleton pregnancy at gestational age 36 weeks or more 3. Able to read and understand Norwegian. 4. Patients will be recruited from the general population at the birth clinic at Oslo University Hospital or the birth clinic of Akershus University Hospital. Signed informed consent form (ICF) and expected cooperation of the patients for the treatment and follow up will be obtained and documented according to ICH GCP, and national/local regulations. Exclusion Criteria: 1. Patients with placenta pathology such as praevia, accreta, pre-eclampsia 2. Patients with bleeding disorders including vonWillebrand disease type I. 3. Known intolerance to one of the two drugs. 4. Patients with prolonged QT-time or other serious cardiac diseases. 5. Liver or kidney failure. 6. Epilepsy. 7. Any medical reason why, in the opinion of the investigator, the patient should not participate.

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Conditions

The condition(s) this trial relates to.

Hemorrhage pregnancy disorder

As listed by the trial registrant

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

Pregnancy complications

Contacts and locations

Locations

  • Akershus University Hospital

    Lørenskog, Norway

  • Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet

    Oslo, 0027, Norway

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