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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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
-
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.