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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Carbetocin; Misoprostol; Oxytocin

Criteria

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.