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

January 24, 2017 updated by: Maged El.Sherif, Ghamra Military Hospital

Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial

Double blinded randomized controlled study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST.

264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used.

Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder.

Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder.

  • All patients will receive general anaesthesia.
  • Operation will be carried out by a three year registrar (at least).
  • Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss.
  • Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation:
  • The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit

Secondary endpoints include:

  1. The need for additional uterotonic medication after carbetocin or oxytocin administration.

    - Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery

    - Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally.

  2. The need for blood transfusion or operative interventions related to PPH

    - The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered.

  3. The change in hemoglobin and hematocrit post versus pre CS

    - The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery.

  4. The hemodynamic adverse effects and the cost-benefit of both drugs.

Study Type

Interventional

Enrollment (Actual)

264

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
        • Ghamra Military Hospital

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:

  • Multiple pregnancy
  • Presence of uterine fibroid
  • Previous Myomectomy
  • Presence of placenta previa
  • Past History of PPH
  • Fetal Macrosomia
  • Polyhydramnios

Exclusion Criteria:

  • Hypertension
  • Preeclampsia
  • Cardiac, Renal, Liver diseases
  • Epilepsy
  • History of 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
Experimental: Carbetocin arm
100 μg intravenous injection at delivery of the anterior shoulder
Drug: Carbetocin
at delivery of anterior shoulder
Other Names:
  • Pabal
Active Comparator: oxytocin arm
5 IU intravenous injection at delivery of the anterior shoulder
Drug: Oxytocin
at delivery of anterior shoulder
Other Names:
  • Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of blood loss
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for another uterotonic medication
Time Frame: 5 minutes
after administration of Carbetocin or Oxytocin
5 minutes
need for blood transfusion or operative intervention
Time Frame: during surgery
during surgery

Collaborators and Investigators

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

Sponsor

Ghamra Military Hospital

Collaborators

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Maged M El.Sherif, Ghamra Military Hospital

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

February 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

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.

Clinical Trials on Postpartum Hemorrhage

Clinical Trials on Carbetocin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe