RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Novo Nordisk A/S • ClinicalTrials.gov ID: NCT07157423

Registry updated: 2026-09-25

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Description

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.

Interventions

Eptacog alfa (NovoSeven) (Drug)
Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)

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

Conditions

Severe Postpartum Haemorrhage

Locations

KLE Belgum — Belagavi, Karnataka, India
Mysore Medical College and Research Institute — Mysore, Karnataka, India
Calicut Medical College — Kozhikode, Kerala, India
Calicut Medical College — Kozhikode, Kerala, India
Seth GS Medical College & KEM Hospital — Mumbai, Maharashtra, India
All India Institute of Medical Sciences_New Dehli — New Delhi, National Capital Territory of Delhi, India
SMS Hospital — Jaipur, Rajasthan, India
SMS Hospital — Jaipur, Rajasthan, India
RNT Medical College — Udaipur, Rajasthan, India
Modern Government Maternity Hospital — Hyderabad, Telangana, India
SN Medical College — Agra, Uttar Pradesh, India
KLE Belgum — Belagavi, India
Post Graduate Institute of Medical Education & Research_Chandigarh — Chandigarh, India
Post Graduate Institute of Medical Education & Research_Chandigarh — Chandigarh, India

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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