Condition category
Pregnancy and Childbirth
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Phil Baker

ORCID ID

Contact details

Central Manchester & Manchester Children's University Hospitals SMH
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom
Philip.Baker@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0453142025

Study information

Scientific title

Acronym

Study hypothesis

To compare the administration of continuous and pulsatile infusion of oxytoxin for labour induction and augmentation.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pregnancy and Childbirth: Labour

Intervention

Randomised controlled trial: pulsatile versus continuous oxytocin administration

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Increase in normal vaginal delivery rate

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/02/2004

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

407 inductions (pulsatile route) 407 augmentations (pulsatile route)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/02/2004

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central Manchester & Manchester Children's University Hospitals SMH
Manchester
M13 0JH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Central Manchester and Manchester Children's University Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding + Tommy's Campaign

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22206748

Publication citations

  1. Results

    Tribe RM, Crawshaw SE, Seed P, Shennan AH, Baker PN, Pulsatile versus continuous administration of oxytocin for induction and augmentation of labor: two randomized controlled trials., Am. J. Obstet. Gynecol., 2012, 206, 3, 230.e1-8, doi: 10.1016/j.ajog.2011.11.001.

Additional files

Editorial Notes