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

Early Phase 1

Completed

• Conditions: Postpartum Hemorrhage; High Risk Pregnancy; Cesarean Section
• Interventions: Drug: Carbetocin; Drug: oxytocin

• Registration Number: NCT04089176
• Lead Sponsor: Rajavithi Hospital

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

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-28
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-31
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-11
• Last Update Submitted: 2019-09-11
• Study First Posted: 2019-09-13
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protocal A	Carbetocin	Carbetocin versus placebo
protocal B	oxytocin	Oxytocin versus placebo
protocal A	oxytocin	Carbetocin versus placebo
protocal B	Carbetocin	Oxytocin versus placebo

Primary Outcome Measures

Name	Time	Method
Additional drug use	during intra-operation	Number of additional drug use after intervention drug

Secondary Outcome Measures

Name	Time	Method
Side effect	During intra-opeartion and acute post operation period as 24 hours post operation	type of side effect
Estimate blood loss	During intra-opeartion and acute post operation period as 24 hours post operation	amount of blood loss
Hemoglobin level	Pre-operation and 24 hours post operation	differentiation of hemoglobin

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand