| Source of record | UK Trials |
| ISRCTN | ISRCTN71488751 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0211184290 |
| Public title | A prospective randomised controlled trial of outpatient versus inpatient labour induction with vaginal controlled - release prostaglandin - E2: Effectiveness and satisfaction |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Pregnancy and Childbirth: Labour induction |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Primigravida
2. Term
3. Singleton pregnancy |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/08/2006 |
| Anticipated end date | 31/07/2007 |
| Status of trial | Completed |
| Target number of participants | 200 |
| Interventions | Inpatient and outpatient groups |
| Primary outcome measure(s) | Effectiveness and satisfaction:
1. Effectiveness defined in terms of proportion of women in labour or delivered within 24hours; 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 measure(s) | Not provided at time of registration |
| Sources of funding | Royal Surrey County Hospital NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr N Mishra |
| Contact details | Royal Surrey County Hospital NHS Trust
Egerton Road
Guildford
United Kingdom
GU2 7XX |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71488751 |
| Date last extracted from ISRCTN register | 17/04/2008 |
