Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean
Keywords
Abstract
Description
A double-blind randomized study conducted on 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 women) after fetal extraction and before placental removal.
Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 09/26/2018 |
| Estimated Enrollment Submitted: | 10/01/2018 |
| First Posted: | 10/02/2018 |
| Last Update Submitted: | 12/31/2019 |
| Last Update Posted: | 01/02/2020 |
| Actual Study Start Date: | 09/30/2018 |
| Estimated Primary Completion Date: | 09/14/2019 |
| Estimated Study Completion Date: | 09/29/2019 |
Condition or disease
Intervention/treatment
Drug: carbetocin
Drug: Syntometrine
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: carbetocin 600 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK). | Drug: carbetocin single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK). |
| Active Comparator: Syntometrine 600 women received one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 micrograms of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes | Drug: Syntometrine one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes |
Eligibility Criteria
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - All participants are at 37 - 40 weeks of gestational age - Noncomplicated pregnancy. - obese women with BMI > 30. Exclusion Criteria: - Participants with placenta previa, - coagulopathy, - preeclamptic - known sensitivity to carbetocin,oxytocin or methergine were excluded |
Outcome
Primary Outcome Measures
1. incidence of postpartum hemorrhage after CS [24 hours]
Secondary Outcome Measures
1. side effects of drugs used [24 hours]
