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ISRCTN
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ISRCTN39772441
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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IMOP
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Serial number at source
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RN04OB007
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Condition - pregnancy,
Indication - cervical ripening prior to induction of labour
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Fetal compromise of sufficient severity such that daily fetal monitoring is scheduled
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Anticipated start date
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01/02/2005
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Anticipated end date
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31/01/2007
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Status of trial
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Completed |
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Patient information material
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Patient information can be found at: https://www.charttrials.abdn.ac.uk/imop/pis.php
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Target number of participants
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300
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Interventions
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Isosorbide mononitrate 40 mg (or placebo) given vaginally 48 hours, 32 hours and 16 hours prior to scheduled admission for induction of labour.
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Primary outcome measure(s)
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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. Women’s experience of induction of labour
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Secondary outcome measure(s)
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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
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Sources of funding
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Wellbeing (Charity) Ref. CT 2004
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Trial website
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https://www.charttrials.abdn.ac.uk/imop/index.php
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16869966
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19624440
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Contact name
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Dr
Jane
Norman
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Address
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University of Glasgow Division of Developmental Medicine
3rd Floor, Queen Elizabeth Building
Glasgow Royal Infirmary
10 Alexandra Parade
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City/town
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Glasgow
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Zip/Postcode
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G31 2ER
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Country
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United Kingdom
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Tel
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+44 (0)141 211 4708
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Fax
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+44 (0)141 553 1367
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Email
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j.e.norman@clinmed.gla.ac.uk
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Sponsor
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Greater Glasgow Health Board (North Glasgow University Hospitals Division) and The University of Glasgow (UK)
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Address
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Research and Development Office
4th Floor, Walton Building
Glasgow Royal Infirmary
84 Castle Street
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City/town
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Glasgow
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Zip/Postcode
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G4 OSF
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Country
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United Kingdom
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Tel
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+44 (0)141 211 0475
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Email
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fiona.graham.gri@northglasgow.scot.nhs.uk
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Date applied
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13/06/2005
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Last edited
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28/07/2009
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Date ISRCTN assigned
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25/07/2005
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