Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

Study Overview
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Brief Summary
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The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

Detailed Description
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The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended. Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.

Official Title
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Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: oxytocin
* Drug: oxytocin plus misoprostol
* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation Exclusion Criteria: gestational age<37 weeks, genital tract trauma, coagulation defect, women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy known hypersensitivity to carbetocin or oxytocin.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

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
Interventional Model Description: This study will be a prospective double-blind randomized study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxytocin<br>The patient will be received oxytocin 20 IU by intravenous infusion | Drug: oxytocin<br>* The patient will be received oxytocin 20 IU by intravenous infusion<br>* Other names: Active comparator;|
| Active Comparator: oxytocin plus misoprostol<br>The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol | Drug: oxytocin<br>* The patient will be received oxytocin 20 IU by intravenous infusion<br>* Other names: Active comparator;Drug: oxytocin plus misoprostol<br>* The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol<br>* Other names: Active Comparator;|
| Active Comparator: Carbetocin<br>The patient will be received Carbetocin 100 mic gm IV | Drug: Carbetocin<br>* The patient received Carbetocin 100 mic gm<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of blood loss | calculation of the amount of blood loss by weighing the swabs and using pictorial charts | 6 hours post delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients develop blood loss more than 1000 ml | Calculation of the number of patients develop blood loss more than 1000 ml | 24 hours post delivery | 
| The number of patient need blood transfusion | Calculation of number of patient need blood transfusion | 24 hours post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Hemorrhage, vaginal delivery, carbetocin, misoprostol, oxytocin