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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39772441
Enrollment
300
Registered
2005-07-25
Start date
2005-02-01
Completion date
Unknown
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical ripening prior to induction of labour Pregnancy and Childbirth Induction of labour

Interventions

Isosorbide mononitrate 40 mg (or placebo) given vaginally 48 hours, 32 hours and 16 hours prior to scheduled admission for induction of labour.

Sponsors

Greater Glasgow Health Board (North Glasgow University Hospitals Division) and The University of Glasgow (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria: Fetal compromise of sufficient severity such that daily fetal monitoring is scheduled

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026