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

Phase 3

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Syntocinon; Drug: Carbetocin; Drug: Misoprostol

• Registration Number: NCT02053922
• Lead Sponsor: Ain Shams University

Brief Summary

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section

Detailed Description

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-27
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

1. Age 18 years or more.
2. Gestational age of pregnancy of 37 completed weeks or more.
3. Written and signed informed consent by the patient to participate in the study.

Exclusion Criteria

1. fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.
2. Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.
3. Women planned to have any other type of uterine incision other than transverse lower segment.
4. Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .
5. 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.
6. Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.
7. Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).
8. Women with history of hypersensitivity to oxytocin or carbetocin.
9. Women with any severe allergic condition or severe asthma.
10. Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.
11. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Syntocinon	Syntocinon	Drug is given just after delivery of the neonate during cesarean section.
Carbetocin	Carbetocin	Drug is given just after delivery of the neonate during cesarean section.
Misoprostol	Misoprostol	Drug is given just after delivery of the neonate during cesarean section.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events recorded during the study.	an expected average 1 week

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt