Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

NCT ID: NCT03693599

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

carbetocin

Intervention Type DRUG

single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).

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

Group Type ACTIVE_COMPARATOR

Syntometrine

Intervention Type DRUG

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

Interventions

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carbetocin

single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

lecturer in obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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faculty of medicine Cairo university

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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carbetocin

Identifier Type: -

Identifier Source: org_study_id

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