Comparison of oral misoprostol with vaginal prostin for induction of labour at term with prolonged rupture of membranes

ISRCTN	ISRCTN57744215
DOI	https://doi.org/10.1186/ISRCTN57744215
Secondary identifying numbers	N0024125766

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Katrina Erskine
Scientific

Department of Obstetrics & Gynaecology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 (0)20 8510 7208
Email	katrina.erskine@homerton.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	1. Is oral misoprostol as safe and effective as vaginal prostin? 2. Is patient satisfaction improved with oral misoprostol? 3. Is there a reduction in caesarean section rate with oral misoprostol?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Labour induction
Intervention	Randomised controlled trial 1. Misoprostol 2. Prostin
Intervention type	Other
Primary outcome measure	1. Time of induction to delivery time 2. Pyrexia in labour 3. Mode of delivery 4. Condition of baby at birth
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2003
Completion date	31/03/2004

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	200
Key inclusion criteria	200 women with term rupture of membranes fitting our inclusion criteria randomised to receive prostin or misoprostol
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/04/2003
Date of final enrolment	31/03/2004

Department of Obstetrics & Gynaecology

London
E9 6SR
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Hospital/treatment centre

Homerton University Hospital NHS Trust (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2008		Yes	No