Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

January 1, 2020 updated by: Ahmed Samy aly ashour, Cairo University

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11231
        • Faculty of Medicine Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postpartum hemorrhage after CS
Time Frame: 24 hours
Number of participants experienced massive postpartum hemorrhage
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects of drugs used
Time Frame: 24 hours
GIT side effects as nausea , vomiting
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ACTUAL)

September 15, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (ACTUAL)

October 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 1, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • carbetocin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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