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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Participants will receive single dose of intravenous bolus injection of eptacog alfa (NovoSeven)
KLE Belgum
Belagavi, Karnataka, India
RECRUITINGCalicut Medical College
Kozhikode, Kerala, India
RECRUITINGCalicut Medical College
Kozhikode, Kerala, India
NOT_YET_RECRUITINGSeth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India
NOT_YET_RECRUITINGSMS Hospital
Jaipur, Rajasthan, India
NOT_YET_RECRUITINGKLE Belgum
Belagavi, India
NOT_YET_RECRUITINGPost Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, India
NOT_YET_RECRUITINGAll India Institute of Medical Sciences_New Dehli
New Delhi, India
NOT_YET_RECRUITINGNumber 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)
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