Misoprostol+Oxytocin vs. Carbetocin in CS
- Conditions
- Cesarean Section
- Interventions
- Registration Number
- NCT02786992
- Lead Sponsor
- Ain Shams University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 600
- Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carbetocin Placebo 100 ug Carbetocin IV Misoprostol + Oxytocin Placebo 400 ug sublingual misoprostol + 10 IU Oxytocin IVI Misoprostol + Oxytocin Misoprostol 400 ug sublingual misoprostol + 10 IU Oxytocin IVI Misoprostol + Oxytocin Oxytocin 400 ug sublingual misoprostol + 10 IU Oxytocin IVI Carbetocin Carbetocin 100 ug Carbetocin IV
- Primary Outcome Measures
Name Time Method incidence of post-partum hemorrhage 24 hours amount of blood loss 24 hours
- Secondary Outcome Measures
Name Time Method Number of participants with NICU admission 24 hours Number of participants needing extra uterotonic drug (10 IU oxytocin IVI) 24 hours An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.
Number of participants needing hemostatic surgical interventions intra-operative Hemoglobin deficit in gm/dl 24 hours difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl
APGAR score at 1 minute and 5 minutes 1 minute and 5 minutes Drug side effects 24 hours Time till resuming bowel habits 24 hours Time of passing gas will be recorded how many hours post-operative
hematocrit deficit in % 24 hours difference between pre-operative and 24 hours post-operative hematocrit in %
Trial Locations
- Locations (1)
Ain Shams University Maternity Hospital
🇪🇬Cairo, Egypt