The EDC is live today — see what ships now
All studies
NCT07157423From ClinicalTrials.govRecruiting

A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India

Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study

  • Severe Postpartum Haemorrhage

At a glance

Phase
Phase 4
Study type
Interventional
Sponsor
Novo Nordisk A/S
Enrolment target
64
Started
26 August 2025
Main results due
26 August 2027
Study sites
14
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

This study will look at how safe is the medicine eptacog alfa when used in women in India for stopping heavy bleeding after giving birth. If participants have heavy bleeding after giving birth then they will get the medicine eptacog alfa. This study will be conducted to get more knowledge on the safety of the medicine eptacog alfa use in these women. At first participants will receive one dose of medicine eptacog alfa. If the given dose is not helpful to stop the bleeding, participants will get one additional dose. The study will last for about 30-35 days.

Study sites(14)

  • KLE Belgum

    Belagavi, Karnataka, India

    Recruiting

  • Mysore Medical College and Research Institute

    Mysore, Karnataka, India

    Recruiting

  • Calicut Medical College

    Kozhikode, Kerala, India

    Recruiting

  • Calicut Medical College

    Kozhikode, Kerala, India

    Not yet recruiting

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, India

    Recruiting

  • All India Institute of Medical Sciences_New Dehli

    New Delhi, National Capital Territory of Delhi, India

    Recruiting

  • SMS Hospital

    Jaipur, Rajasthan, India

    Completed

  • SMS Hospital

    Jaipur, Rajasthan, India

    Not yet recruiting

  • RNT Medical College

    Udaipur, Rajasthan, India

    Not yet recruiting

  • Modern Government Maternity Hospital

    Hyderabad, Telangana, India

    Recruiting

  • SN Medical College

    Agra, Uttar Pradesh, India

    Recruiting

  • KLE Belgum

    Belagavi, India

    Not yet recruiting

  • Post Graduate Institute of Medical Education & Research_Chandigarh

    Chandigarh, India

    Recruiting

  • Post Graduate Institute of Medical Education & Research_Chandigarh

    Chandigarh, India

    Not yet recruiting

Showing 14 of 14 sites. 8 of the 14 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07157423. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth | Trialion