Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Blood Loss; Postpartum Hemorrhage

Treatments: Drug: Syntometrine; Drug: carbetocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02044549

Carbitocin

Details and patient eligibility

About

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Full description

A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 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

Enrollment: 300 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All participants are at 37 - 40 weeks of gestational age
• Noncomplicated pregnancy.

Exclusion criteria

• Participants with placenta previa
• Patients with coagulopathy
• preeclamptic women
• known sensitivity to oxytocin or methergine were excluded

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

carbetocin

Active Comparator group

Description:

single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.

Treatment:

Drug: carbetocin

Syntometrine

Active Comparator group

Description:

Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.

Treatment:

Drug: Syntometrine