NCT02304042

Brief Summary

250 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). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. The investigators will not include a control group for ethical reasons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2014

Shorter than P25 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

November 1, 2014

Completed
25 days 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

November 26, 2014

Last Update Submit

July 1, 2015

Conditions

Delivery

Outcome Measures

Primary Outcomes (1)

  • Need for other uterotonics

    After giving the drug, the uterine tone will be felt and amount of bleeding will be estimated.

    2 minutes after giving the drug

Secondary Outcomes (1)

  • Bleeding>500ml

    2 minutes after giving the drug.

Study Arms (2)

Carbetocin

ACTIVE COMPARATOR

125 women will receive carbetocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder

Drug: Carbetocin

Oxytocin

ACTIVE COMPARATOR

125 women will receive carbetocin oxytocin after delivery of the anterior shoulder. The drug will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder

Drug: Oxytocin

Interventions

CarbetocinDRUG

Carbetocin will be given slowly iv after delivery of the anterior shoulder.

Carbetocin
OxytocinDRUG

Oxytocin will be given slowly iv after delivery of the anterior shoulder.

Oxytocin

Eligibility Criteria

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

You may qualify if:

  • Women with at least 2 risk factors for developing PPH. Risk factors include previous PPH, BMI\>35, multiple pregnancy, prolonged labour \>12 hours, ultrasound estimated fetal weight\>4kg and induction of labour.

You may not qualify if:

  • Gestational age \<37 weeks
  • Placenta previa
  • Hypertension.
  • Preeclampsia.
  • Cardiac, renal or liver diseases
  • 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 (2)

  • 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

  • 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

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
DOUBLE
Who Masked
PARTICIPANT, 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 26, 2014

First Posted

December 1, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 2, 2015

Record last verified: 2015-07

Locations

EG(2)