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

March 4, 2014 updated by: Dr Robabeh Taheripanah, Shahid Beheshti University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2

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

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1985717443
        • Infertility and Reproductive Health Research Center

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxytocin
A single 100 microgram IV dose of carbetocin after operation
Drug: Oxytocin
Oxytocin with 30 international units (IU) IV infusion was used in this investigation
Other Names:
  • Pitocin
EXPERIMENTAL: Carbetocin
A standard 30 international units (IU) IV infusion of oxytocin during two hours
Drug: Carbetocin
Carbetocin with single 100 microg IV dosage was used in this investigation
Other Names:
  • Lonactene
  • Duratocin,
  • Pabal,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
screening of Cessation of bleeding
Time Frame: screening until 24 hours after placenta disconnection
screening until 24 hours after placenta disconnection
time duration to stop bleeding in the case of post-cesarean section
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Robabeh Taheripanah, MD-Gyn., Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran

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

September 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRHRC-021
  • JANU2014TAHERIPANAH

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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