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

Early Phase 1CompletedNCT04089176

Department of Medical Services Ministry of Public Health of Thailand120 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Postpartum Hemorrhage Cesarean Section High Risk Pregnancy

Interventions

CarbetocinDRUG

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

oxytocinDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rajavithi Hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

Additional drug use

Number of additional drug use after intervention drug

Time frame: during intra-operation

Secondary Outcomes

Estimate blood loss

amount of blood loss

Time frame: During intra-opeartion and acute post operation period as 24 hours post operation

Side effect

type of side effect

Time frame: During intra-opeartion and acute post operation period as 24 hours post operation

Hemoglobin level

differentiation of hemoglobin

Time frame: Pre-operation and 24 hours post operation

Data from ClinicalTrials.gov

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