Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

Study Overview
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Brief Summary
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Double blinded randomized controlled study

Detailed Description
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Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST. 264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used. Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder. Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder. All patients will receive general anaesthesia. Operation will be carried out by a three year registrar (at least). Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss. Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation: The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit Secondary endpoints include: The need for additional uterotonic medication after carbetocin or oxytocin administration. - Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery - Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally. The need for blood transfusion or operative interventions related to PPH - The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered. The change in hemoglobin and hematocrit post versus pre CS - The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery. The hemodynamic adverse effects and the cost-benefit of both drugs.

Official Title
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Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Carbetocin
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple pregnancy Presence of uterine fibroid Previous Myomectomy Presence of placenta previa Past History of PPH Fetal Macrosomia Polyhydramnios Exclusion Criteria: Hypertension Preeclampsia Cardiac, Renal, Liver diseases Epilepsy History of hypersensitivity to Carbetocin

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbetocin arm<br>100 μg intravenous injection at delivery of the anterior shoulder | Drug: Carbetocin<br>* at delivery of anterior shoulder<br>* Other names: Pabal;|
| Active Comparator: oxytocin arm<br>5 IU intravenous injection at delivery of the anterior shoulder | Drug: Oxytocin<br>* at delivery of anterior shoulder<br>* Other names: Syntocinon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of blood loss |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for another uterotonic medication | after administration of Carbetocin or Oxytocin | 5 minutes | 
| need for blood transfusion or operative intervention |  | during surgery | 

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