Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/11/2010
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 Katrina Erskine

ORCID ID

Contact details

Department of Obstetrics & Gynaecology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7208
katrina.erskine@homerton.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0024125766

Study information

Scientific title

Acronym

Study hypothesis

1. Is oral misoprostol as safe and effective as vaginal prostin?
2. Is patient satisfaction improved with oral misoprostol?
3. Is there a reduction in caesarean section rate with oral misoprostol?

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

Treatment

Patient information sheet

Condition

Pregnancy and Childbirth: Labour induction

Intervention

Randomised controlled trial
1. Misoprostol
2. Prostin

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Time of induction to delivery time
2. Pyrexia in labour
3. Mode of delivery
4. Condition of baby at birth

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

200 women with term rupture of membranes fitting our inclusion criteria randomised to receive prostin or misoprostol

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/2003

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Obstetrics & Gynaecology
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18569470

Publication citations

  1. Results

    Parisaei M, Erskine KJ, Is expensive always better? Comparison of two induction agents for term rupture of membranes., J Obstet Gynaecol, 2008, 28, 3, 290-293, doi: 10.1080/01443610802042951.

Additional files

Editorial Notes