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
Not Applicable
Completed
- Conditions
- Cervical ripening prior to induction of labourPregnancy and ChildbirthInduction of labour
- Registration Number
- ISRCTN39772441
- Lead Sponsor
- Greater Glasgow Health Board (North Glasgow University Hospitals Division) and The University of Glasgow (UK)
- Brief Summary
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16869966 2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19624440
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 300
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
Exclusion Criteria
Fetal compromise of sufficient severity such that daily fetal monitoring is scheduled
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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)<br> ii. Costs to the health service of induction of labour<br> iii. Women?s experience of induction of labour<br>
- Secondary Outcome Measures
Name Time Method <br> iv. Operative delivery rates<br> v. Incidence of unscheduled admission for reasons other than labour commencing<br> vi. Duration and frequency of neonatal admissions to special care<br> 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)<br> viii. Length of labour<br> ix. Oxytocin augmentation rates<br> x. Epidural usage<br> xi. Proportion with unfavourable cervix at 24 hours after admission<br> xii. Requirement for additional inpatient cervical ripening agent<br>