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Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

Primary Purpose

Postpartum Hemorrhage, Blood Loss

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
carbetocin
Syntometrine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Carbetocin, syntometrine, postpartum hemorrhage, cesarean section

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All participants are at 37 - 40 weeks of gestational age
  • Noncomplicated pregnancy.

Exclusion Criteria:

  • Participants with placenta previa
  • Patients with coagulopathy
  • preeclamptic women
  • known sensitivity to oxytocin or methergine were excluded

Sites / Locations

  • Ahmed Maged

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

carbetocin

Syntometrine

Arm Description

single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.

Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.

Outcomes

Primary Outcome Measures

prevention of post partum hemorrhage after CS
Number of participants experienced postpartum hemorrhage

Secondary Outcome Measures

side effects of drugs used
Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching

Full Information

First Posted
January 15, 2014
Last Updated
June 23, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02044549
Brief Title
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
Official Title
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section
Detailed Description
A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal. Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Blood Loss
Keywords
Carbetocin, syntometrine, postpartum hemorrhage, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbetocin
Arm Type
Active Comparator
Arm Description
single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.
Arm Title
Syntometrine
Arm Type
Active Comparator
Arm Description
Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
Intervention Type
Drug
Intervention Name(s)
carbetocin
Other Intervention Name(s)
Pabal
Intervention Description
Oxycontin analogue
Intervention Type
Drug
Intervention Name(s)
Syntometrine
Other Intervention Name(s)
Oxytocin methergine combination
Intervention Description
Uterotonins
Primary Outcome Measure Information:
Title
prevention of post partum hemorrhage after CS
Description
Number of participants experienced postpartum hemorrhage
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
side effects of drugs used
Description
Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants are at 37 - 40 weeks of gestational age Noncomplicated pregnancy. Exclusion Criteria: Participants with placenta previa Patients with coagulopathy preeclamptic women known sensitivity to oxytocin or methergine were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Ass prof kasr aini medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Maged
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

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Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

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