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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04089176

Enrollment

120

Registered

2019-09-13

Start date

2019-02-01

Completion date

2019-05-31

Last updated

2019-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, High Risk Pregnancy, Postpartum Hemorrhage

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

Interventions

DRUGCarbetocin

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

DRUGoxytocin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Additional drug use	during intra-operation	Number of additional drug use after intervention drug

Secondary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026