Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-04-30

Brief Summary

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

The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Hemorrhage

NCT03578263

Cesarean Section Complications

COMPLETED NA

Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

NCT02391636

Postpartum Hemorrhage

COMPLETED PHASE4

Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section

NCT02079558

Postpartum Hemorrhage

COMPLETED PHASE2

Carbetocin vs. Oxytocin at Elective Cesarean Section

NCT03168698

Postpartum Hemorrhage

COMPLETED NA

Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH

NCT04089176

Postpartum Hemorrhage Cesarean Section High Risk Pregnancy

COMPLETED EARLY_PHASE1

Detailed Description

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

* Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
* Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
* A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
* A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
* Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
* Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
* A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni\_suef University Hospitals.
* Inclusion criteria:

• Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
* Exclusion criteria

* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
* Hypertension with pregnancy.
* Cardiac and coronary diseases with pregnancy
* Women included in the study were divided into 2 groups:

.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.

.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U \& ergometrine 0.2 mg.

Conditions

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

Bleeding Anemia

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

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Pabal ( carbetocin)

Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head.

Group Type ACTIVE_COMPARATOR

Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head

Intervention Type DRUG

In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.

Oxytocin and Methergine (methyl ergometrine)

The second group of patients included in the study will be given Oxytocin 5 IU ampoule by intravenous infusion and Methergine 0.2 mg IV after delivery of fetal head.

Group Type ACTIVE_COMPARATOR

Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv

Intervention Type DRUG

In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv

Interventions

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

Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head

In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.

Intervention Type DRUG

Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv

In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv

Intervention Type DRUG

Other Intervention Names

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

Carbetocin Oxytocin and Methyl ergometrine

Eligibility Criteria

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

Inclusion Criteria

* • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.

Exclusion Criteria

* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
* Hypertension with pregnancy.
* Cardiac and coronary diseases with pregnancy

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No