Postpartum Hemorrhage Clinical Trial
Official title:
Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an
estimated mortality of 140 000 per year. Uterine atony is one of the most important causes
of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the
most conventional drug which was proved effective. However, it has the shortcomings of short
half life and the necessity of intravenous administration. Misopristol, and more recently
Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.
Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin
for treatment of atonic PPH.
The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena,
Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered
vaginally will be invited to participate in the study. Patients who delivered by caesarean
section, with retained placenta, with traumatic PPH, associated coagulopathy and those
refused to participate in the study will be excluded. The patients will be randomly
categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously;
the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will
receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops
containing computer-generated codes. The primary outcome of the study is cessation of
bleeding which will be judged by visual inspection of the blood loss by the trialist and by
loss of < 300 mL of blood during the first hour after enrollment. The secondary outcomes are
time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL),
changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite
values (%) before and after treatment, the use of additional uterotonic drugs, the rate of
complications (%), and the necessity for surgical intervention, and the cost of each
medication.
Written consent will be obtained from all participants and approval from the local
institutional ethical committee will be included.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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