NCT02391636

Brief Summary

Double blinded randomized controlled study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2015

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

Study Start

First participant enrolled

February 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

February 17, 2015

Last Update Submit

January 24, 2017

Conditions

Postpartum Hemorrhage

Keywords

Postpartum Hemorrhagecarbetocinoxytocin

Outcome Measures

Primary Outcomes (1)

  • amount of blood loss

    24 hours

Secondary Outcomes (2)

  • need for another uterotonic medication

    5 minutes

  • need for blood transfusion or operative intervention

    during surgery

Study Arms (2)

Carbetocin arm

EXPERIMENTAL

100 μg intravenous injection at delivery of the anterior shoulder

Drug: Carbetocin

oxytocin arm

ACTIVE COMPARATOR

5 IU intravenous injection at delivery of the anterior shoulder

Drug: Oxytocin

Interventions

CarbetocinDRUG

at delivery of anterior shoulder

Also known as: Pabal
Carbetocin arm
OxytocinDRUG

at delivery of anterior shoulder

Also known as: Syntocinon
oxytocin arm

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Multiple pregnancy
  • Presence of uterine fibroid
  • Previous Myomectomy
  • Presence of placenta previa
  • Past History of PPH
  • Fetal Macrosomia
  • Polyhydramnios

You may not qualify if:

  • Hypertension
  • Preeclampsia
  • Cardiac, Renal, Liver diseases
  • Epilepsy
  • History of hypersensitivity to Carbetocin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghamra Military Hospital

Cairo, Cairo Governorate, Egypt

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 Officials

  • Maged M El.Sherif

    Ghamra Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registrar of OB/GYN

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 18, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

EG(1)