Cesarean Section
Conditions
Keywords
Misoprostol, Oxytocin, Carbetocin, Prevention, Post-partum hemorrhage
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.
Interventions
DRUGMisoprostol
DRUGOxytocin
DRUGCarbetocin
DRUGPlacebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of post-partum hemorrhage | 24 hours |
| amount of blood loss | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Time till resuming bowel habits | 24 hours | Time of passing gas will be recorded how many hours post-operative |
| Number of participants with NICU admission | 24 hours | — |
| Drug side effects | 24 hours | — |
| APGAR score at 1 minute and 5 minutes | 1 minute and 5 minutes | — |
| hematocrit deficit in % | 24 hours | difference between pre-operative and 24 hours post-operative hematocrit in % |
Countries
Egypt
Outcome results
None listed