Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCH 02-17
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to find out whether oxytocin reduces Caesarean Section Rates to assess its effects on other labour and neonatal outcomes and in particular to assess its effects on maternal perception of pain etc and satisfaction with labour.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Pregnancy and childbirth: Childbirth
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
A scientific evaluation of a widely introduced but as yet unproven labour intervention. It will look at the health gain in terms of any subsequent psychological dysfunction. The effects of the different interventions on the Caesarean Section Rates is another primary outcome measure. Any reduction in the Caesarean Section Rate is likely to have economic benefit to the NHS in terms of cost reduction.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/1998
Overall trial end date
01/02/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Women in spontaneous labour in their first pregnancy at term (37-42 weeks). There must be a singleton vertex presentation with no significant antenatal or intrapartum problems.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Added December 2008: 412
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/1998
Recruitment end date
01/02/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Obstetrics and Gynaecology
Sunderland
SR4 7TP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Mother and Child Health National Research and Development Programme (UK)
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715415
Publication citations
-
Results
Hinshaw K, Simpson S, Cummings S, Hildreth A, Thornton J, A randomised controlled trial of early versus delayed oxytocin augmentation to treat primary dysfunctional labour in nulliparous women., BJOG, 2008, 115, 10, 1289-95; discussion 1295-6, doi: 10.1111/j.1471-0528.2008.01819.x.