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 |
| Secondary identifying numbers | LWH315 |
- Submission date
- 21/07/2005
- Registration date
- 09/09/2005
- Last edited
- 06/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Leanne Bricker
Scientific
Scientific
Liverpool Women's Hospital NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
United Kingdom
Study information
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Misoprostol, dinoprostone, oxytocin |
| Primary outcome measure | 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 study start date | 01/02/2002 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1890 (758 final recruitment) |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool Women's Hospital NHS Foundation Trust
Liverpool
L8 7SS
United Kingdom
L8 7SS
United Kingdom
Sponsor information
Liverpool Women's Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
University Departments
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
England
United Kingdom
"ROR" |
https://ror.org/04q5r0746 |
|---|
Funders
Funder type
Government
Liverpool Women's Hospital NHS Foundation Trust (UK)
No information available
NHS Support Funds
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2008 | Yes | No |
