Eptacog alfa to stop heavy bleeding after childbirth in India
Official title: Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study
Run by Novo Nordisk A/S · NCT07157423 · Data updated 2026-11-12
This will test whether the medicine eptacog alfa can safely stop severe bleeding in women in India after childbirth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 64 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 14 sites (Belagavi, Karnataka and 13 other locations) |
| Status | Recruiting |
| Started | August 26, 2025 |
| Main results expected | August 26, 2027 |
| Study ends | August 26, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07157423 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (≥18 years) delivering after 27 weeks in India who develop severe postpartum haemorrhage that fails to respond to uterotonics are eligible.
✕Probably not a fit
Women with a history of thromboembolism, known bleeding disorders, disseminated intravascular coagulation (DIC), HELLP syndrome, or other listed exclusions are not expected to benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4, multi-center study gives eptacog alfa to adult women in India who develop severe postpartum haemorrhage that does not respond to standard uterotonics. Participants receive one dose of eptacog alfa and, if bleeding continues, may receive a second dose, with monitoring for adverse events. The main focus is on safety, including monitoring for thromboembolic events and other complications, with follow-up lasting about 30–35 days. The study is sponsored by Novo Nordisk and conducted at participating hospitals in Karnataka and Kerala.
Why it matters
Potential benefit: If successful, eptacog alfa could provide an additional option to rapidly control severe postpartum bleeding and reduce related complications.
How similar studies have gone: Use of eptacog alfa for postpartum hemorrhage has been reported in case series and small studies with some success, but results are mixed and concerns about thrombotic risk remain.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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KLE Belgum
Belagavi, Karnataka, India Recruiting -
Mysore Medical College and Research Institute
Mysore, Karnataka, India Recruiting -
Calicut Medical College
Kozhikode, Kerala, India 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 -
Modern Government Maternity Hospital
Hyderabad, Telangana, India Recruiting
Show 8 more locations
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SN Medical College
Agra, Uttar Pradesh, India Recruiting -
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, India Recruiting -
Calicut Medical College
Kozhikode, Kerala, India Not yet recruiting -
SMS Hospital
Jaipur, Rajasthan, India Completed -
SMS Hospital
Jaipur, Rajasthan, India Not yet recruiting -
RNT Medical College
Udaipur, Rajasthan, India Not yet recruiting -
KLE Belgum
Belagavi, India Not yet recruiting -
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, India Not yet recruiting
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
Similar studies
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Estimating Platelet Counts with ROTEM PLTEM in Laboring Women with Low Platelets or Heavy Bleeding
This study tests whether the PLTEM value from ROTEM sigma testing can quickly estimate platelet count in pregnant women with low platelets or severe postpartum hemorrhage to help decisions about anesthesia and transfusions.
-
Using the Alma System to treat severe bleeding after childbirth
This study is testing whether the Alma System can safely and effectively stop severe bleeding after childbirth in women who have experienced postpartum hemorrhage.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.