The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)

Study Overview
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Brief Summary
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The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section

Detailed Description
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The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section.

Official Title
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The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Syntocinon
* Drug: Carbetocin
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or more. Gestational age of pregnancy of 37 completed weeks or more. Written and signed informed consent by the patient to participate in the study. Exclusion Criteria: fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize. Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only. Women planned to have any other type of uterine incision other than transverse lower segment. Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy . Women with placental abruption are excluded because there is a higher risk of hemorrhage with this condition and it was therefore felt to be inappropriate to recruit these women. Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy. Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes). Women with history of hypersensitivity to oxytocin or carbetocin. Women with any severe allergic condition or severe asthma. Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Syntocinon<br>Drug is given just after delivery of the neonate during cesarean section. | Drug: Syntocinon<br>* Syntocinon ampoules (10 IU Oxytocin). (Novartis Pharma, Egypt) One ampoule 10 IU diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS, followed by an intravenous drip of 20 IU oxytocin in 500 ml saline over 4 hours.<br>|
| Active Comparator: Carbetocin<br>Drug is given just after delivery of the neonate during cesarean section. | Drug: Carbetocin<br>* Carbetocin (Ampoule 100 μg/ml) . [Pabal, Marketing Authorization Holder: Ferring GmbH (Gesellschaft mit beschränkter Haftung), Kiel ,Germany. Manufactured by DRAXIS Pharma , a division of specialty Pharmaceuticals Inc. Montreal ,Canada] ,diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS.<br>* Other names: Pabal;|
| Active Comparator: Misoprostol<br>Drug is given just after delivery of the neonate during cesarean section. | Drug: Misoprostol<br>* Misoprostol (200 mcg Tablet) [Misotac, Sigma Pharmaceutical Industries, SAE, Egypt] Two tablets (400 mcg) in the buccal space just after delivery of the neonate during CS.<br>* Other names: Misotac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section |  | an expected average 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events recorded during the study. |  | an expected average 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean section, ecbolics, postpartum hemorrhage