Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/11/2014
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

Mr Kevin Harrington

ORCID ID

Contact details

Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7544
kevin.harrington@virgin.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0024112467

Study information

Scientific title

Acronym

Study hypothesis

Can we reduce the induction to delivery interval and Caesarean section rate in postdates primigravida women undergoing induction of labour with unfavourable cervix?

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: Induction of labour

Intervention

1. Mifepristone
2. Standard care

Intervention type

Drug

Phase

Not Applicable

Drug names

Mifepristone

Primary outcome measures

1. Length of time from induction start (first Prostin) to:
1.1. Onset of labour
1.2. Second stage
1.3. Delivery
1.4.Timing and type of intervention (Caesarian Section, Forceps, Ventouse), if any
2. Antepartum haemorrhage (APH), postpartum haemorrhage (PPH) and other complications
3. Neonatal weight, cord pH and admission to Special Care Baby Unit (SCBU)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2002

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

100 pregnant primiparous women who have not laboured at or beyond 41 weeks of gestation with cervival length >3 cm.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2002

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Fetal Medicine Unit
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Homerton University Hospital NHS Trust (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

Publication citations

Additional files

Editorial Notes