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.
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