Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Undergoing Caesarean Sections for Placenta Previa: A Randomised Controlled Trial

January 20, 2017 updated by: AbdelGany Hassan, Cairo University

The study aims at comparing the roles of carbetocin and oxytocin in the prevention of atonic PPH in women undergoing CS for placenta previa.

200 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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. 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.

Placenta praevia exists when the placenta is inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound imaging according to what is relevant clinically: if the placenta lies over the internal cervical os, it is considered a major praevia; if the leading edge of the placenta is in the lower uterine segment but not covering the cervical os, minor or partial praevia exists.

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 cesarean section (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 placenta previa covering, or less than 2cm from the internal cervical os will be approached in the antenatal clinic. 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.

The exclusion criteria will be gestational age <37 weeks, hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy, need for general anaesthesia, known hypersensitivity to carbetocin and suspected placenta accreta.

200 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 anaesthetist slowly intravenously after delivery of the baby. The investigators will not include a control group for ethical reasons.

The CS will be done in the presence of a consultant Obstetrician and a consultant anaesthetist, cross-matched blood will be ready and a level 2 critical care bed will be available. CS will be done through the lower uterine segment, if the placenta is encountered, it will be pushed aside and the baby will be delivered.

The allocated drug will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. 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, using pictorial charts and estimating the amount of blood in the suction containers. Blood haemoglobin will be assessed 24 hours after the CS.

Study Type

Interventional

Enrollment (Anticipated)

500

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 Contact

Study Locations

  • Egypt
      • BeniSuef, Egypt
        • Recruiting
        • BeniSuef University hospitals
      • Cairo, Egypt
        • Recruiting
        • Cairo University hospitals
        • Sub-Investigator:
          • Mohamed MM Kotb, MD
        • Contact:

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

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing CS for placenta previa

Exclusion Criteria:

  • Gestational age <37 weeks
  • Hypertension
  • Preeclampsia
  • Cardiac, renal or liver diseases
  • Need for general anaesthesia
  • Known hypersensitivity to carbetocin
  • Suspected placenta accreta

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carbetocin
100 µgm of Carbetocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. 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.
Drug: Carbetocin
Carbetocin will be given slowly iv after delivery of the baby
Active Comparator: Oxytocin
5 mg of oxytocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. 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.
Drug: Oxytocin
Oxytocin will be given slowly iv after delivery of the baby

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for other uterotonic drugs
Time Frame: 2 minutes after giving the drug
If the uterus is not contracted 2 minutes after giving the drug, further uterotonic drugs will be given.
2 minutes after giving the drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of PPH
Time Frame: 2 minutes after giving the drug.
PPH will be diagnosed when bleeding exceeds 500ml
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 (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPH1

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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