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
Protocol serial number	N0016158062
Sponsor	Department of Health
Funders	Hammersmith Hospital NHS Trust (UK), Hammersmith Hospital Pharmacy, NHS R&D Support Funding 2004/05

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Douglas Keith Edmonds
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
Email	dkedmonds@hhnt.org

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	prostaglandin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/11/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Women's & Children's Services

London
W12 0HS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011		Yes	No