| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN74323479 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0024112467 |
| Public title | What shall we do with the postdates woman who is not in labour? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Pregnancy and Childbirth: Induction of labour |
| Study hypothesis | Can we reduce the induction to delivery interval and Caesarean Section rate in postdates primigravida women undergoing induction of labour with unfavourable cervix? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 100 Pregnant primiparous women who have not laboured at or beyond 41 weeks of gestation with cervival length >3 cm. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/05/2002 |
| Anticipated end date | 31/12/2003 |
| Status of trial | Completed |
| Target number of participants | 100 |
| Interventions | Randomised controlled trial:
A. Mifepristone
B. Standard care |
| Primary outcome measure(s) | 1. Length of time from induction start (first Prostin) to:
1.1 Onset of labour
1.2 Second stage
1.3 Delivery
1.4.Timing and type of intervention (Caesarian Section, Forceps, Ventouse), if any
2. Antepartum haemorrhage (APH), postpartum haemorrhage (PPH) and other complications, and
3. Neonatal weight, cord pH and admission to Special Care Baby Unit (SCBU). |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Homerton University Hospital NHS Trust |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| 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 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Mr Kevin Harrington |
| Contact details | Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
London
United Kingdom
E9 6SR |
| Contact telephone | +44 020 8510 7544 |
| Contact fax | +44 020 8510 7544 |
| Contact email | kevin.harrington@virgin.net |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN74323479 |
| Date last extracted from ISRCTN register | 17/04/2008 |
