Misoprostol+Oxytocin vs. Carbetocin in CS

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cesarean Section

Treatments: Drug: Placebo; Drug: Oxytocin; Drug: Misoprostol; Drug: Carbetocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02786992

AS1301

Details and patient eligibility

About

This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.

Enrollment: 600 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).

Exclusion criteria

• hypersensitivity to oxytocin, carbetocin or prostaglandins
• contraindication to prostaglandins (e.g. glaucoma)
• history of significant heart disease
• severe asthma
• epilepsy
• history or evidence of liver
• renal or vascular disease
• history of coagulopathy
• thrombocytopenia or anticoagulant therapy
• women with HELLP syndrome
• eclampsia
• women presenting by placental abruption
• contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Misoprostol + Oxytocin

Active Comparator group

Description:

400 ug sublingual misoprostol + 10 IU Oxytocin IVI

Treatment:

Drug: Misoprostol

Drug: Placebo

Drug: Oxytocin

Carbetocin

Active Comparator group

Description:

100 ug Carbetocin IV

Treatment:

Drug: Carbetocin

Drug: Placebo