RecruitingPhase 4

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

India64 participantsStarted 2025-08-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 interventi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of thromboembolic events

Timeframe: From baseline (day 0) to end of study (day 30)

Trial details

NCT IDNCT07157423

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-26

Contact for this trial

Novo Nordisk

(+1) 866-867-7178 clinicaltrials@novonordisk.com

View on ClinicalTrials.gov More Severe Postpartum Haemorrhage trials