NCT04089176

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

April 28, 2019

Last Update Submit

September 11, 2019

Conditions

Postpartum HemorrhageCesarean SectionHigh Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Additional drug use

    Number of additional drug use after intervention drug

    during intra-operation

Secondary Outcomes (3)

  • Estimate blood loss

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

  • Side effect

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

  • Hemoglobin level

    Pre-operation and 24 hours post operation

Study Arms (2)

protocal A

ACTIVE COMPARATOR

Carbetocin versus placebo

Drug: CarbetocinDrug: oxytocin

protocal B

ACTIVE COMPARATOR

Oxytocin versus placebo

Drug: CarbetocinDrug: oxytocin

Interventions

CarbetocinDRUG

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

protocal Aprotocal B
oxytocinDRUG

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

protocal Aprotocal B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • previous history of postpartum hemorrhage
  • polyhydramnios
  • fetal macrosomia
  • previous cesarean section
  • grand multiparity
  • intramural myoma
  • chorioamnionitis
  • prolonged premature rupture of membrane
  • augmentation of labour

You may not qualify if:

  • pregnancy induce hypertension
  • on anticoagulant
  • placenta previa or placenta percreta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocinOxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2019

First Posted

September 13, 2019

Study Start

February 1, 2019

Primary Completion

April 30, 2019

Study Completion

May 31, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations

TH(1)