NCT02303418

Brief Summary

The study aims at comparing the roles of carbetocin and oxytocin in the prevention of atonic PPH in women undergoing CS for placenta previa. 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

55
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 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

Study Start

First participant enrolled

November 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

November 25, 2014

Last Update Submit

January 20, 2017

Conditions

Post Partum Haemorrhage

Keywords

Obstetrics

Outcome Measures

Primary Outcomes (1)

  • Need for other uterotonic drugs

    If the uterus is not contracted 2 minutes after giving the drug, further uterotonic drugs will be given.

    2 minutes after giving the drug

Secondary Outcomes (1)

  • Development of PPH

    2 minutes after giving the drug.

Study Arms (2)

Carbetocin

ACTIVE COMPARATOR

100 µgm of Carbetocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.

Drug: Carbetocin

Oxytocin

ACTIVE COMPARATOR

5 mg of oxytocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.

Drug: Oxytocin

Interventions

CarbetocinDRUG

Carbetocin will be given slowly iv after delivery of the baby

Carbetocin
OxytocinDRUG

Oxytocin will be given slowly iv after delivery of the baby

Oxytocin

Eligibility Criteria

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

You may qualify if:

  • Women undergoing CS for placenta previa

You may not qualify if:

  • Gestational age \<37 weeks
  • Hypertension
  • Preeclampsia
  • Cardiac, renal or liver diseases
  • Need for general anaesthesia
  • Known hypersensitivity to carbetocin
  • Suspected placenta accreta

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 (2)

  • 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: 17567419RESULT

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

Central Study Contacts

AbdelGany MA Hassan, MRCOG, MD

CONTACT

+201017801604abdelgany2@gmail.com

Study Design

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

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

EG(2)