A Phase 4 interventional study of Eptacog alfa (NovoSeven) in Severe Postpartum Haemorrhage, sponsored by Novo Nordisk A/S. Recruiting at 14 sites in India. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment
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.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 64 is below the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)
Drug: Eptacog alfa (NovoSeven)
Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)
Number of thromboembolic events
Measured as number of events
Time frame: From baseline (day 0) to end of study (day 30)
Number of serious adverse events
Measured as number of events
Time frame: From baseline (day 0) to end of study (day 30)
Number of allergic reactions
Measured as number of allergic reactions
Time frame: From baseline (day 0) to end of study (day 30)
All medication errors
Measured as number of all medication errors
Time frame: Baseline (day 0)
Near medication errors
Measured as number of near medication errors
Time frame: Baseline (day 0)
Not enrolling at this site.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Aug 2027, 24 months after the start.
Of 28 phase 4 interventional studies under Postpartum Hemorrhage, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's planned 24 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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