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

April 9, 2015 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Interventional

Enrollment (Actual)

200

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
      • Cairo, Egypt
        • Nesreen Abdel Fattah Abdullah Shehata

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

20 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • Carbetocin
Active Comparator: 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.
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
Other Names:
  • Oxytocin and Methyl ergometrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine tone and size
Time Frame: One hour after the cesarean section
The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.
One hour after the cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: One hour after cesarean section
Blood loss will be estimated postoperatively by giving each woman of each group standard 2 dressings (standard weight of dressing is 25 gm) for one hour postoperative and recording weight of blood soaked dressings and volume of lost blood.
One hour after cesarean section

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin concentration
Time Frame: Before and 24 hours after the operation
Changes in hemoglobin concentrations before and 24 hours postoperative. Using a 10% fall in hematocrit value to define post-partum hemorrhage.
Before and 24 hours after the operation

Collaborators and Investigators

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

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Nesreen A Shehata, MD, Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 29, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beni-Suef 3

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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