Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

NCT ID: NCT02044549

Last Updated: 2021-06-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage Blood Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

carbetocin

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

Group Type ACTIVE_COMPARATOR

carbetocin

Intervention Type DRUG

Oxycontin analogue

Syntometrine

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

Group Type ACTIVE_COMPARATOR

Syntometrine

Intervention Type DRUG

Uterotonins

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

carbetocin

Oxycontin analogue

Intervention Type DRUG

Syntometrine

Uterotonins

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pabal Oxytocin methergine combination

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed M Maged, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Ass prof kasr aini medical school

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ahmed Maged

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Carbitocin

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.