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Recruiting NCT07157423

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

Phase IV Interventional Severe Postpartum Haemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eptacog alfa (NovoSeven).
Who it may be relevant to
Registry conditions: Severe Postpartum Haemorrhage. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety of Eptacog Alfa in Severe Postpartum Haemorrhage in India: A Phase IV Interventional Study

Overview

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.

Interventions

  • Drug Eptacog alfa (NovoSeven)
    Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)

Primary outcome measures

  • Number of thromboembolic events [Time frame: From baseline (day 0) to end of study (day 30)]
Secondary outcome measures (4)
  • Number of serious adverse events [Time frame: From baseline (day 0) to end of study (day 30)]
  • Number of allergic reactions [Time frame: From baseline (day 0) to end of study (day 30)]
  • All medication errors [Time frame: Baseline (day 0)]
  • Near medication errors [Time frame: Baseline (day 0)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

India · 10 centers
  • KLE Belgum — Belagavi
  • Calicut Medical College — Kozhikode
  • Calicut Medical College — Kozhikode
  • Seth GS Medical College & KEM Hospital — Mumbai
  • All India Institute of Medical Sciences_New Dehli — New Delhi
  • SMS Hospital — Jaipur
  • SMS Hospital — Jaipur
  • KLE Belgum — Belagavi
  • … and 2 more centers

Identifiers

NCT: NCT07157423 · NN7711-7717 · U1111-1289-2568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗