Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: carbetocin
* Drug: misopristol
* Drug: oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary atonic postpartum hemorrhage after vaginal delivery Exclusion Criteria: Patients who delivered by caesarean section Retained placenta Traumatic postpartum hemorrhage Associated coagulopathy Chronic medical illness (hepatic , renal diseases) Refusal to participate in the study.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage | Drug: oxytocin<br>* 30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage<br>|
| Active Comparator: carbetocin<br>10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage | Drug: carbetocin<br>* 10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage<br>* Other names: pabal;|
| Active Comparator: misopristol<br>600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage | Drug: misopristol<br>* 600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage<br>* Other names: Misotac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| control of postpartum hemorrhage |  | within 20 minutes of administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum hemorrhage, oxytocin, carbetocin, misopristol