What shall we do with the postdates woman who is not in labour?
| ISRCTN | ISRCTN74323479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74323479 |
| Secondary identifying numbers | N0024112467 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 02/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Kevin Harrington
Scientific
Scientific
Fetal Medicine Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 (0)20 8510 7544 |
|---|---|
| kevin.harrington@virgin.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | What shall we do with the postdates woman who is not in labour? |
| Study objectives | Can we reduce the induction to delivery interval and Caesarean section rate in postdates primigravida women undergoing induction of labour with unfavourable cervix? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Induction of labour |
| Intervention | 1. Mifepristone 2. Standard care |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mifepristone |
| Primary outcome measure | 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 3. Neonatal weight, cord pH and admission to Special Care Baby Unit (SCBU) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2002 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | 100 pregnant primiparous women who have not laboured at or beyond 41 weeks of gestation with cervival length >3 cm. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Fetal Medicine Unit
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Homerton University Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/06/2017: No publications found in PubMed, verifying study status with principal investigator
