NCT02410759

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 ergometrine 0.5mg (methergin®, Novartis, Switzerland).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

March 31, 2015

Last Update Submit

July 3, 2016

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Need for other uterotonics

    The uterus will be felt for the tone.

    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 IM

Drug: Carbetocin

Ergometrine

ACTIVE COMPARATOR

100 women with atonic PPH will receive Ergometrine 0.5mg IM

Drug: Ergometrine

Interventions

CarbetocinDRUG

100 women with atonic PPH will receive Carbetocin 100 µgm IM

Carbetocin
ErgometrineDRUG

100 women with atonic PPH will receive Ergometrine 0.5 µgm IM

Ergometrine

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

RECRUITING

Cairo university hospitals

Cairo, Egypt

RECRUITING

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

Conditions

Postpartum Hemorrhage

Interventions

carbetocinErgonovine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • AbdelGany M Hassan

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AbdelGany MA Hassan, MRCOG, MD

CONTACT

+201017801604abdelgany2@gmail.com

Study Design

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

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 8, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

EG(2)