Status:
RECRUITING
A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Severe Postpartum Haemorrhage
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 26 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT07157423
Start Date
August 26 2025
End Date
March 26 2027
Last Update
September 5 2025
Active Locations (8)
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1
KLE Belgum
Belagavi, Karnataka, India, 590010
2
Calicut Medical College
Kozhikode, Kerala, India, 673008
3
Calicut Medical College
Kozhikode, Kerala, India, 673008
4
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India, 400012