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
Secondary identifying numbers	RN04OB007

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Jane Norman
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
Email	j.e.norman@clinmed.gla.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information can be found at: https://www.charttrials.abdn.ac.uk/imop/pis.php
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Isosorbide mononitrate (IMN)
Primary outcome measure	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) ii. Costs to the health service of induction of labour iii. Womens experience of induction of labour
Secondary outcome measures	iv. Operative delivery rates v. Incidence of unscheduled admission for reasons other than labour commencing vi. Duration and frequency of neonatal admissions to special care vii. Incidence of adverse maternal and fetal outcomes such as uterine hypercontractility, postpartum haemorrhage (maternal outcomes) and meconium stained liquor, five minute Apgar of less than seven (fetal outcomes) viii. Length of labour ix. Oxytocin augmentation rates x. Epidural usage xi. Proportion with unfavourable cervix at 24 hours after admission xii. Requirement for additional inpatient cervical ripening agent
Overall study start date	01/02/2005
Completion date	31/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Scotland
United Kingdom

Study participating centre

University of Glasgow Division of Developmental Medicine

Glasgow
G31 2ER
United Kingdom

Sponsor information

Greater Glasgow Health Board (North Glasgow University Hospitals Division) and The University of Glasgow (UK)
Hospital/treatment centre

Research and Development Office
4th Floor, Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 OSF
United Kingdom

Phone	+44 (0)141 211 0475
Email	fiona.graham.gri@northglasgow.scot.nhs.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

Wellbeing (Charity) Ref. CT 2004

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	25/07/2006		Yes	No
Results article	results	01/08/2009		Yes	No

Editorial Notes

16/03/2020: Internal review.