Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH

September 11, 2019 updated by: Rajavithi Hospital

Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial

Objective: study efficacy of carbtocin versus oxytocin for prevention postpartum hemorrhage in high risk pregnancy who undergo cesarean section

Study Overview

Detailed Description

Randomized controlled clinical trial. Defined patient in two group. Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Early Phase 1

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

      • Bangkok, Thailand, 10400
        • Rajavithi 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • previous history of postpartum hemorrhage
  • polyhydramnios
  • fetal macrosomia
  • previous cesarean section
  • grand multiparity
  • intramural myoma
  • chorioamnionitis
  • prolonged premature rupture of membrane
  • augmentation of labour

Exclusion Criteria:

  • pregnancy induce hypertension
  • on anticoagulant
  • placenta previa or placenta percreta

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: protocal A
Carbetocin versus placebo
carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr
Active Comparator: protocal B
Oxytocin versus placebo
carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional drug use
Time Frame: during intra-operation
Number of additional drug use after intervention drug
during intra-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate blood loss
Time Frame: During intra-opeartion and acute post operation period as 24 hours post operation
amount of blood loss
During intra-opeartion and acute post operation period as 24 hours post operation
Side effect
Time Frame: During intra-opeartion and acute post operation period as 24 hours post operation
type of side effect
During intra-opeartion and acute post operation period as 24 hours post operation
Hemoglobin level
Time Frame: Pre-operation and 24 hours post operation
differentiation of hemoglobin
Pre-operation and 24 hours post operation

Collaborators and Investigators

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

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 (Actual)

February 1, 2019

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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