Randomised placebo controlled trial of outpatient cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour - clinical trial with analyses of efficacy, cost effectiveness and acceptability
| ISRCTN | ISRCTN39772441 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39772441 |
| Protocol serial number | RN04OB007 |
| Sponsor | Greater Glasgow Health Board (North Glasgow University Hospitals Division) and The University of Glasgow (UK) |
| Funder | Wellbeing (Charity) Ref. CT 2004 |
- Submission date
- 13/06/2005
- Registration date
- 25/07/2005
- Last edited
- 16/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University of Glasgow Division of Developmental Medicine
3rd Floor, Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
| Phone | +44 (0)141 211 4708 |
|---|---|
| j.e.norman@clinmed.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised placebo controlled trial of outpatient cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour - clinical trial with analyses of efficacy, cost effectiveness and acceptability |
| Study acronym | IMOP |
| Study objectives | Outpatient isosorbide mononitrate will result in a shorter inpatient stay before delivery, decreased costs to the health service, and greater maternal satisfaction with induction of labour, compared with placebo treatment |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cervical ripening prior to induction of labour |
| Intervention | Isosorbide mononitrate 40 mg (or placebo) given vaginally 48 hours, 32 hours and 16 hours prior to scheduled admission for induction of labour. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Isosorbide mononitrate (IMN) |
| Primary outcome measure(s) |
i. Elapsed time interval from hospital admission to vaginal delivery (defined as the time from admission for inpatient induction or admission in labour to delivery) |
| Key secondary outcome measure(s) |
iv. Operative delivery rates |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Bishop score less than or equal to 6 2. Singleton pregnancy 3. Nulliparity 4. Gestation greater than or equal to 37 completed weeks 5. Willing to self administer vaginal tablets |
| Key exclusion criteria | Fetal compromise of sufficient severity such that daily fetal monitoring is scheduled |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
G31 2ER
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 25/07/2006 | Yes | No | |
| Results article | results | 01/08/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/03/2020: Internal review.
