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Clinical Trials in India / NCT07157423
Recruiting Phase 4

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

NCT07157423 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 4
Started
2025-08-26
Last updated
2026-08-13

Condition(s) studied

Severe Postpartum Haemorrhage

Investigational drug(s) / intervention(s)

Eptacog alfa (NovoSeven)

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

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
KLE Belgum Belagavi Karnataka Recruiting
Mysore Medical College and Research Institute Mysore Karnataka Not Yet Recruiting
Calicut Medical College Kozhikode Kerala Recruiting
Calicut Medical College Kozhikode Kerala Not Yet Recruiting
Seth GS Medical College & KEM Hospital Mumbai Maharashtra Recruiting
All India Institute of Medical Sciences_New Dehli New Delhi National Capital Territory of Delhi Recruiting
SMS Hospital Jaipur Rajasthan Completed
SMS Hospital Jaipur Rajasthan Not Yet Recruiting
RNT Medical College Udaipur Rajasthan Not Yet Recruiting
Modern Government Maternity Hospital Hyderabad Telangana Not Yet Recruiting
SN Medical College Agra Uttar Pradesh Not Yet 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

More Novo Nordisk A/S trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157423 on ClinicalTrials.gov ↗ ← All trials in India