NCT02044549

Brief Summary

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

January 15, 2014

Last Update Submit

June 23, 2021

Conditions

Postpartum HemorrhageBlood Loss

Keywords

Carbetocinsyntometrinepostpartum hemorrhagecesarean section

Outcome Measures

Primary Outcomes (1)

  • prevention of post partum hemorrhage after CS

    Number of participants experienced postpartum hemorrhage

    24 hours

Secondary Outcomes (1)

  • side effects of drugs used

    24 hours

Study Arms (2)

carbetocin

ACTIVE COMPARATOR

single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.

Drug: carbetocin

Syntometrine

ACTIVE COMPARATOR

Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.

Drug: Syntometrine

Interventions

carbetocinDRUG

Oxycontin analogue

Also known as: Pabal
carbetocin
SyntometrineDRUG

Uterotonins

Also known as: Oxytocin methergine combination
Syntometrine

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All participants are at 37 - 40 weeks of gestational age
  • Noncomplicated pregnancy.

You may not qualify if:

  • Participants with placenta previa
  • Patients with coagulopathy
  • preeclamptic women
  • known sensitivity to oxytocin or methergine were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maged

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Postpartum HemorrhageHemorrhage

Interventions

carbetocinsyntometrine

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahmed Maged, MD

    Ass prof kasr aini medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 24, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 24, 2021

Record last verified: 2021-06

Locations

EG(1)