Actively Recruiting
A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India
Led by Novo Nordisk A/S · Updated on 2026-03-27
64
Participants Needed
8
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before any study activities
- Adult women aged 18 years or older
- Delivered after 27 weeks of pregnancy
- Diagnosed with severe postpartum haemorrhage not responding to uterotonics
You will not qualify if you...
- Previously participated in this study
- Mental incapacity, unwillingness, or language barriers preventing understanding or cooperation
- History of thromboembolism
- History of bleeding disorders
- History or presence of severe childbirth complications such as disseminated intravascular coagulation, HELLP syndrome, thrombotic thrombocytopenic purpura, or pre-eclampsia (apart from severe postpartum haemorrhage)
- Underwent invasive obstetric procedures for current bleeding before enrollment (excluding uterine balloon tamponade and external aortic compression)
- Any chronic or severe disease that might risk safety or compliance
- Participation in any other interventional clinical study before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
KLE Belgum
Belagavi, Karnataka, India, 590010
Actively Recruiting
2
Calicut Medical College
Kozhikode, Kerala, India, 673008
Actively Recruiting
3
Calicut Medical College
Kozhikode, Kerala, India, 673008
Not Yet Recruiting
4
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
5
All India Institute of Medical Sciences_New Dehli
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
6
SMS Hospital
Jaipur, Rajasthan, India, 302004
Not Yet Recruiting
7
KLE Belgum
Belagavi, India, 590010
Not Yet Recruiting
8
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, India, 160012
Not Yet Recruiting
Research Team
N
Novo Nordisk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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