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)
Number of thromboembolic events — From baseline (day 0) to end of study (day 30) Measured as number of events
Trial sites (14)
Facility
City
Region
Status
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
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.
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