Completed

A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section

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What is being tested

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

+ Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv

Drug
Who is being recruted

Urogenital Diseases+10

+ Anemia

+ Female Urogenital Diseases and Pregnancy Complications

From 20 to 30 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 2014
See protocol details

Summary

Principal SponsorBeni-Suef University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2014

Actual date on which the first participant was enrolled.

* 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.

Official TitleA Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section
NCT02101567
Principal SponsorBeni-Suef University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAnemiaFemale Urogenital Diseases and Pregnancy ComplicationsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePostpartum HemorrhageObstetric Labor ComplicationsPathologic ProcessesPregnancy ComplicationsPuerperal DisordersPathological Conditions, Signs and SymptomsUterine Hemorrhage

Criteria

1 inclusion criteria required to participate
• Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.

4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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 II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Nesreen Abdel Fattah Abdullah Shehata

Cairo, EgyptOpen Nesreen Abdel Fattah Abdullah Shehata in Google Maps
CompletedOne Study Center