Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LWH315
Study information
Scientific title
Acronym
The PROMMIS Trial - Prelabour Rupture Of the Membranes and MISoprostol
Study hypothesis
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
Not provided at time of registration
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Induction of labour
Intervention
Randomisation to dinoprostone or misoprostol
Intervention type
Drug
Phase
Not Specified
Drug names
Misoprostol, dinoprostone, oxytocin
Primary outcome measures
1. Caesarean section (measure of safety)
2. Vaginal delivery within 24 hours of trial entry (measure of clinical effectiveness)
Secondary outcome measures
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
Overall trial start date
01/02/2002
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1890 (758 final recruitment)
Participant exclusion criteria
1. Multiple pregnancy
2. Breech presentation
3. Previous Caesarean section
Recruitment start date
01/02/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Women's Hospital NHS Foundation Trust
Liverpool
L8 7SS
United Kingdom
Funders
Funder type
Government
Funder name
Liverpool Women's Hospital NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS Support Funds
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18752586
Publication citations
-
Results
Bricker L, Peden H, Tomlinson AJ, Al-Hussaini TK, Idama T, Candelier C, Luckas M, Furniss H, Davies A, Kumar B, Roberts J, Alfirevic Z, Titrated low-dose vaginal and/or oral misoprostol to induce labour for prelabour membrane rupture: a randomised trial., BJOG, 2008, 115, 12, 1503-1511, doi: 10.1111/j.1471-0528.2008.01890.x.