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

NCT ID: NCT04089176

Last Updated: 2019-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-05-31

Brief Summary

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

Detailed Description

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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

Conditions

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Postpartum Hemorrhage Cesarean Section High Risk Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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protocal A

Carbetocin versus placebo

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min

oxytocin

Intervention Type DRUG

oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr

protocal B

Oxytocin versus placebo

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min

oxytocin

Intervention Type DRUG

oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr

Interventions

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Carbetocin

carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min

Intervention Type DRUG

oxytocin

oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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T.Sopida

Identifier Type: -

Identifier Source: org_study_id

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