A comparison of the effectiveness of prostaglandin gel and tablet preparations in induction of labour at term.
| ISRCTN | ISRCTN70152691 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70152691 |
| Secondary identifying numbers | N0016158062 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Douglas Keith Edmonds
Scientific
Scientific
Women's & Children's Services
Queen Charlottes & Chelsea Hospital
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0)20 8383 5239 |
|---|---|
| dkedmonds@hhnt.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Is Prostin (dinoprostone) gel more effective in induction of labour than Prostin tablets? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Labour induction |
| Intervention | Prostil gel vs Prostil tablet |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | prostaglandin |
| Primary outcome measure | 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 study start date | 01/11/2004 |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 165 |
| Key inclusion criteria | Outpatients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Women's & Children's Services
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Hammersmith Hospital NHS Trust (UK)
No information available
Hammersmith Hospital Pharmacy
No information available
NHS R&D Support Funding 2004/05
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2011 | Yes | No |
