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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089176
• Other study ID #: T.Sopida
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2019
• Est. completion date: May 31, 2019

Study information

• Verified date: September 2019
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Hemorrhage
• High Risk Pregnancy
• Postpartum Hemorrhage

Intervention

Drug:
• Carbetocin
carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
• oxytocin
oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Additional drug use	Number of additional drug use after intervention drug	during intra-operation
Secondary	Estimate blood loss	amount of blood loss	During intra-opeartion and acute post operation period as 24 hours post operation
Secondary	Side effect	type of side effect	During intra-opeartion and acute post operation period as 24 hours post operation
Secondary	Hemoglobin level	differentiation of hemoglobin	Pre-operation and 24 hours post operation