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Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Primary Purpose

Post Partum Hemorrhage

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 Post Partum Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All participants are at 37 - 40 weeks of gestational age
  • Noncomplicated pregnancy.
  • obese women with BMI > 30.

Exclusion Criteria:

  • Participants with placenta previa,
  • coagulopathy,
  • preeclamptic
  • known sensitivity to carbetocin,oxytocin or methergine were excluded

Sites / Locations

  • faculty of medicine Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

carbetocin

Syntometrine

Arm Description

600 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).

600 women received one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 micrograms of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes

Outcomes

Primary Outcome Measures

incidence of postpartum hemorrhage after CS
Number of participants experienced massive postpartum hemorrhage

Secondary Outcome Measures

side effects of drugs used
GIT side effects as nausea , vomiting

Full Information

First Posted
September 27, 2018
Last Updated
January 1, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03693599
Brief Title
Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean
Official Title
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
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 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 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
Post Partum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbetocin
Arm Type
Experimental
Arm Description
600 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Arm Title
Syntometrine
Arm Type
Active Comparator
Arm Description
600 women received one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 micrograms of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes
Intervention Type
Drug
Intervention Name(s)
carbetocin
Intervention Description
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Intervention Type
Drug
Intervention Name(s)
Syntometrine
Intervention Description
one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes
Primary Outcome Measure Information:
Title
incidence of postpartum hemorrhage after CS
Description
Number of participants experienced massive postpartum hemorrhage
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
side effects of drugs used
Description
GIT side effects as nausea , vomiting
Time Frame
24 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants are at 37 - 40 weeks of gestational age Noncomplicated pregnancy. obese women with BMI > 30. Exclusion Criteria: Participants with placenta previa, coagulopathy, preeclamptic known sensitivity to carbetocin,oxytocin or methergine were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine Cairo university
City
Giza
ZIP/Postal Code
11231
Country
Egypt

12. IPD Sharing Statement

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Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

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