A randomised trial to evaluate misoprostol for induction of labour following prelabour rupture of the amniotic membranes

ISRCTN	ISRCTN57007037
DOI	https://doi.org/10.1186/ISRCTN57007037
Protocol serial number	LWH315
Sponsor	Liverpool Women's Hospital NHS Foundation Trust (UK)
Funders	Liverpool Women's Hospital NHS Foundation Trust (UK), NHS Support Funds

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Leanne Bricker
Scientific

Liverpool Women's Hospital NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
United Kingdom

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The PROMMIS Trial - Prelabour Rupture Of the Membranes and MISoprostol
Study objectives	Vaginal misoprostol for cervical priming followed by titrated oral misoprostol is as safe and effective as dinoprostone and/or oxytocin for induction of labour in the presence of prelabour rupture of membranes (PROM)
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Induction of labour
Intervention	Randomisation to dinoprostone or misoprostol
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol, dinoprostone, oxytocin
Primary outcome measure(s)	1. Caesarean section (measure of safety) 2. Vaginal delivery within 24 hours of trial entry (measure of clinical effectiveness)
Key secondary outcome measure(s)	1. Labour 2. Delivery 3. Pueperium 4. Neonatal Morbidity 5. Satisfaction - Women's satisfaction, Caregiver's satisfaction 6. Womens' and midwives' views and experiences of participating in the PROMMIS Trial
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1890
Key inclusion criteria	1. Decision to induce labour in the presence of PROM 2. >34 weeks gestation 3. Singleton, live fetus 4. Normal admission cardiotocograph (CTG)
Key exclusion criteria	1. Multiple pregnancy 2. Breech presentation 3. Previous Caesarean section
Date of first enrolment	01/02/2002
Date of final enrolment	31/12/2005

Liverpool Women's Hospital NHS Foundation Trust

Liverpool
L8 7SS
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	01/11/2008		Yes	No