Condition category
Pregnancy and Childbirth
Date applied
21/07/2005
Date assigned
09/09/2005
Last edited
06/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Leanne Bricker

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Liverpool Women's Hospital NHS Foundation Trust (UK)

Sponsor details

University Departments
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Sponsor type

Government

Website

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

  1. 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.

Additional files

Editorial Notes