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New study tests clotting drug to stop dangerous bleeding after birth

NCT ID NCT07157423

Disease control Sponsor: Novo Nordisk A/S 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study is testing the safety of a medicine called eptacog alfa (NovoSeven) for women in India who have severe bleeding after giving birth. 64 women who do not respond to standard treatments will receive one or two doses of the drug. Researchers will monitor for blood clots, allergic reactions, and other serious side effects over about a month.

What this could mean

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

Active substance
eptacog alfa (NovoSeven)
What this could lead to
If successful, this could confirm that eptacog alfa is a safe option for stopping severe bleeding after childbirth in Indian women.
What could go wrong
This is a small, single-arm safety study with no comparison group, so it cannot prove the drug works better than standard care. There is a risk of blood clots or allergic reactions.

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 64 people

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

Started

Aug 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study except for blood loss estimation post-partum * Adult women aged greater than or equal to (≥) 18 years at the time of signing the informed consent and who deliver after 27 weeks diagnosed with severe postpartum haemorrhage (PPH) who fail to respond to uterotonics Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Patient with a history of thromboembolism * Patient with a history of bleeding disorders * Patient with a history of or ongoing disseminated intravascular coagulation (DIC); haemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome, thrombotic thrombocytopenic purpura (TTP), pre-eclampsia or other severe complication of childbirth apart from severe PPH * Have undergone invasive obstetric procedures for the ongoing haemorrhage prior to trial enrolment (uterine balloon tamponade and external aortic compression not included) * Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise patient's safety or compliance with the protocol * Participation (i.e., signed informed consent) in any other interventional clinical study prior to screening in the current study

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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.

Severe postpartum haemorrhage

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • All India Institute of Medical Sciences_New Dehli

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Calicut Medical College

    RECRUITING

    Kozhikode, Kerala, 673008, India

  • Calicut Medical College

    NOT_YET_RECRUITING

    Kozhikode, Kerala, 673008, India

  • KLE Belgum

    RECRUITING

    Belagavi, Karnataka, 590010, India

  • KLE Belgum

    NOT_YET_RECRUITING

    Belagavi, 590010, India

  • Modern Government Maternity Hospital

    NOT_YET_RECRUITING

    Hyderabad, Telangana, 500064, India

  • Mysore Medical College and Research Institute

    NOT_YET_RECRUITING

    Mysore, Karnataka, 570001, India

  • Post Graduate Institute of Medical Education & Research_Chandigarh

    RECRUITING

    Chandigarh, 160012, India

  • Post Graduate Institute of Medical Education & Research_Chandigarh

    NOT_YET_RECRUITING

    Chandigarh, 160012, India

  • RNT Medical College

    NOT_YET_RECRUITING

    Udaipur, Rajasthan, 313001, India

  • SMS Hospital

    COMPLETED

    Jaipur, Rajasthan, 302004, India

  • SMS Hospital

    NOT_YET_RECRUITING

    Jaipur, Rajasthan, 302004, India

  • SN Medical College

    NOT_YET_RECRUITING

    Agra, Uttar Pradesh, 282003, India

  • Seth GS Medical College & KEM Hospital

    RECRUITING

    Mumbai, Maharashtra, 400012, India