A prospective randomised controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction

ISRCTN	ISRCTN71488751
DOI	https://doi.org/10.1186/ISRCTN71488751
Secondary identifying numbers	N0211184290

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

Dr N Mishra
Scientific

Royal Surrey County Hospital NHS Trust
Egerton Road
Guildford
GU2 7XX
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	We hypothesize that the slow release mechanism of vaginal insert would be effective in achieving both cervical ripening and labour onset and patient would be more satisfied remaining at home.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Labour induction
Intervention	Inpatient and outpatient groups
Intervention type	Other
Primary outcome measure	Effectiveness and satisfaction: 1. Effectiveness defined in terms of proportion of women in labour or delivered within 24 hours; requirement for additional intervention e.g. epidural 2. Satisfaction defined as proportion of women with high mean ratings after 12 hours insertion/after delivery
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2006
Completion date	31/07/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	200
Key inclusion criteria	1. Primigravida 2. Term 3. Singleton pregnancy
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2006
Date of final enrolment	31/07/2007

Royal Surrey County Hospital NHS Trust

Guildford
GU2 7XX
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal Surrey County Hospital NHS Trust (UK)

No information available

NHS R&D Support Funding (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