Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
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

Dr Kim Hinshaw

ORCID ID

Contact details

Obstetrics and Gynaecology
City Hospitals Sunderland NHS Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom
+44 (0)191 5656256

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes