NCT02304055

Brief Summary

200 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

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

May 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

November 26, 2014

Last Update Submit

January 26, 2016

Conditions

Obstetrics

Outcome Measures

Primary Outcomes (1)

  • Need for other uterotonics

    The uterus will be felt or the tone and the amount of bleeding will be estimated.

    2 minutes after giving the drug

Secondary Outcomes (1)

  • Development of Major PPH

    10 minutes after giving the drug

Study Arms (2)

Carbetocin

ACTIVE COMPARATOR

100 women with atonic PPH will receive Carbetocin 100 µgm slowly iv.

Drug: Carbetocin

Oxytocin

ACTIVE COMPARATOR

100 women with atonic PPH will receive oxytocin 5IU slowly iv.

Drug: Oxytocin

Interventions

CarbetocinDRUG

100 women with atonic PPH will receive Carbetocin 100 µgm slowly iv.

Carbetocin
OxytocinDRUG

100 women with atonic PPH will receive Oxytocin 5IU slowly iv.

Oxytocin

Eligibility Criteria

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

You may qualify if:

  • Women with atonic PPH.

You may not qualify if:

  • Gestational age \<37 weeks.
  • Hypertension.
  • Preeclampsia.
  • Cardiac, renal or liver diseases
  • Epilepsy.
  • Known hypersensitivity to Carbetocin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BeniSuef University hospitals

BeniSuef, Egypt

Location

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (3)

  • Moertl MG, Friedrich S, Kraschl J, Wadsack C, Lang U, Schlembach D. Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial. BJOG. 2011 Oct;118(11):1349-56. doi: 10.1111/j.1471-0528.2011.03022.x. Epub 2011 Jun 14.

    PMID: 21668768BACKGROUND

  • Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. doi: 10.1111/j.1471-0528.2007.01377.x.

    PMID: 17567419BACKGROUND

  • Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.

    PMID: 33232518DERIVED

MeSH Terms

Interventions

carbetocinOxytocin

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 1, 2014

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

EG(2)