Post Partum Hemorrhage
Conditions
Brief summary
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section
Detailed 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
Interventions
DRUGcarbetocin
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
DRUGSyntometrine
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postpartum hemorrhage after CS | 24 hours | Number of participants experienced massive postpartum hemorrhage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| side effects of drugs used | 24 hours | GIT side effects as nausea , vomiting |
Countries
Egypt
Outcome results
None listed