Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Delivered Vaginally With at Least 2 Risk Factors for Atonic PPH: A Randomised Controlled Trial (PPH)

July 1, 2015 updated by: AbdelGany Hassan, Cairo University
250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. The investigators will not include a control group for ethical reasons.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries (1). Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.

Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.

Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections.

Carbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony after child birth by CS under epidural or spinal anaesthesia. Carbetocin has a rapid onset of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of sustained uterine response with contractions of higher amplitude and frequency. Its safety profile is comparable to that of oxytocin.

The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients with at least 2 risk factors for developing atonic PPH will be approached in the antenatal clinic or early in labour if appropriate. Risk factors include previous PPH, BMI>35, multiple pregnancy, prolonged labour >12 hours, fetal macrosomia>4kg and induction of labour. Women will be invited to participate in the study, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study.

250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. We will not include a control group for ethical reasons.

The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug. Blood loss will be estimated through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24 hours after delivery.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

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
      • BeniSuef, Egypt
        • BeniSuef University hospitals
      • Cairo, Egypt
        • Cairo University hospitals

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with at least 2 risk factors for developing PPH. Risk factors include previous PPH, BMI>35, multiple pregnancy, prolonged labour >12 hours, ultrasound estimated fetal weight>4kg and induction of labour.

Exclusion Criteria:

  • Gestational age <37 weeks
  • Placenta previa
  • Hypertension.
  • Preeclampsia.
  • Cardiac, renal or liver diseases
  • Known hypersensitivity to Carbetocin.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carbetocin
125 women will receive carbetocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder
Drug: Carbetocin
Carbetocin will be given slowly iv after delivery of the anterior shoulder.
Active Comparator: Oxytocin
125 women will receive carbetocin oxytocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder
Drug: Oxytocin
Oxytocin will be given slowly iv after delivery of the anterior shoulder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for other uterotonics
Time Frame: 2 minutes after giving the drug
After giving the drug, the uterine tone will be felt and amount of bleeding will be estimated.
2 minutes after giving the drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding>500ml
Time Frame: 2 minutes after giving the drug.
The amount of bleeding will be estimated 2 minutes after giving the drug.
2 minutes after giving the drug.

Collaborators and Investigators

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

Sponsor

Cairo 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.

General Publications

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

November 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (Estimate)

December 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPH 2

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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