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
Protocol serial number	N0211184290
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Royal Surrey County Hospital NHS Trust (UK), NHS R&D Support Funding (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2007

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

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