Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Post Partum Hemorrhage

Treatments: Drug: carbetocin; Drug: Syntometrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03693599

carbetocin

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 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

Enrollment: 1,200 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,200 participants in 2 patient groups

carbetocin

Experimental group

Description:

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).

Treatment:

Drug: carbetocin

Syntometrine

Active Comparator group

Description:

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

Treatment:

Drug: Syntometrine