Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0211184290
Study information
Scientific title
Acronym
Study hypothesis
We hypothesize that the slow release mechanism of vaginal insert would be effective in achieving both cervical ripening and labour onset and patient would be more satisfied remaining at home.
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: Labour induction
Intervention
Inpatient and outpatient groups
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Effectiveness and satisfaction:
1. Effectiveness defined in terms of proportion of women in labour or delivered within 24 hours; requirement for additional intervention e.g. epidural
2. Satisfaction defined as proportion of women with high mean ratings after 12 hours insertion/after delivery
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2006
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primigravida
2. Term
3. Singleton pregnancy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2006
Recruitment end date
31/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Surrey County Hospital NHS Trust
Guildford
GU2 7XX
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Surrey County Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (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