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

Primary Purpose

Postpartum Hemorrhage, Cesarean Section, High Risk Pregnancy

Status
Completed
Phase
Early Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Carbetocin
oxytocin
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

protocal A

protocal B

Arm Description

Carbetocin versus placebo

Oxytocin versus placebo

Outcomes

Primary Outcome Measures

Additional drug use
Number of additional drug use after intervention drug

Secondary Outcome Measures

Estimate blood loss
amount of blood loss
Side effect
type of side effect
Hemoglobin level
differentiation of hemoglobin

Full Information

First Posted
April 28, 2019
Last Updated
September 11, 2019
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04089176
Brief Title
Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH
Official Title
Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnant Women With High Risk Postpartum Hemorrhage: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Cesarean Section, High Risk Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
protocal A
Arm Type
Active Comparator
Arm Description
Carbetocin versus placebo
Arm Title
protocal B
Arm Type
Active Comparator
Arm Description
Oxytocin versus placebo
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Intervention Description
carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
Intervention Type
Drug
Intervention Name(s)
oxytocin
Intervention Description
oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr
Primary Outcome Measure Information:
Title
Additional drug use
Description
Number of additional drug use after intervention drug
Time Frame
during intra-operation
Secondary Outcome Measure Information:
Title
Estimate blood loss
Description
amount of blood loss
Time Frame
During intra-opeartion and acute post operation period as 24 hours post operation
Title
Side effect
Description
type of side effect
Time Frame
During intra-opeartion and acute post operation period as 24 hours post operation
Title
Hemoglobin level
Description
differentiation of hemoglobin
Time Frame
Pre-operation and 24 hours post operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

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

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