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Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Carbetocin
Oxytocin
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postpartum Hemorrhage focused on measuring prevention, cesarean section

Eligibility Criteria

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

Inclusion Criteria:

  • At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin

Exclusion Criteria:

  • Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia

Sites / Locations

  • Infertility and Reproductive Health Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxytocin

Carbetocin

Arm Description

A single 100 microgram IV dose of carbetocin after operation

A standard 30 international units (IU) IV infusion of oxytocin during two hours

Outcomes

Primary Outcome Measures

screening of Cessation of bleeding
time duration to stop bleeding in the case of post-cesarean section

Secondary Outcome Measures

Full Information

First Posted
January 13, 2014
Last Updated
March 4, 2014
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02079558
Brief Title
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Official Title
Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
prevention, cesarean section

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
A single 100 microgram IV dose of carbetocin after operation
Arm Title
Carbetocin
Arm Type
Experimental
Arm Description
A standard 30 international units (IU) IV infusion of oxytocin during two hours
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Duratocin,, Pabal,, Lonactene
Intervention Description
Carbetocin with single 100 microg IV dosage was used in this investigation
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Oxytocin with 30 international units (IU) IV infusion was used in this investigation
Primary Outcome Measure Information:
Title
screening of Cessation of bleeding
Time Frame
screening until 24 hours after placenta disconnection
Title
time duration to stop bleeding in the case of post-cesarean section
Time Frame
24 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin Exclusion Criteria: Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robabeh Taheripanah, MD-Gyn.
Organizational Affiliation
Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infertility and Reproductive Health Research Center
City
Tehran
ZIP/Postal Code
1985717443
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28707488
Citation
Taheripanah R, Shoman A, Karimzadeh MA, Zamaniyan M, Malih N. Efficacy of oxytocin versus carbetocin in prevention of postpartum hemorrhage after cesarean section under general anesthesia: a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2807-2812. doi: 10.1080/14767058.2017.1355907. Epub 2017 Jul 25.
Results Reference
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Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section

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