Condition category
Pregnancy and Childbirth
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
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 Douglas Keith Edmonds

ORCID ID

Contact details

Women's & Children's Services
Queen Charlottes & Chelsea Hospital
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 5239
dkedmonds@hhnt.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016158062

Study information

Scientific title

Acronym

Study hypothesis

Is Prostin (dinoprostone) gel more effective in induction of labour than Prostin tablets?

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

Not Specified

Patient information sheet

Condition

Pregnancy and Childbirth: Labour induction

Intervention

Prostil gel vs Prostil tablet

Intervention type

Drug

Phase

Not Specified

Drug names

prostaglandin

Primary outcome measures

1. Mode of delivery and indication
2. Time in labour
3. Number of doses of prostaglandin needed
4. Cervical dilation at transfer to labour Ward.
5. Frequency of artificial rupture of membranes
6. Frequency of oxytocin use
7. Frequency of meconium staining of liquor
8. Frequency of uterine tachysystole/hyperstimulation
9. Frequency of need for foetal blood sampling in labour
10. Frequency of need for neonatal resuscitation or transfer to Neonatal Unit

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2004

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Outpatients

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

165

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2004

Recruitment end date

01/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Women's & Children's Services
London
W12 0HS
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

Hammersmith Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hammersmith Hospital Pharmacy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding 2004/05

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21429067

Publication citations

  1. Results

    Taher SE, Inder JW, Soltan SA, Eliahoo J, Edmonds DK, Bennett PR, Prostaglandin E2 vaginal gel or tablets for the induction of labour at term: a randomised controlled trial., BJOG, 2011, 118, 6, 719-725, doi: 10.1111/j.1471-0528.2011.02901.x.

Additional files

Editorial Notes