NCT00843362

24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Università degli Studi di Brescia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the synthetic prostaglandins most commonly used to achieve cervical ripening and labour induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical) or as a controlled-release intravaginal pessary. The controlled-release pessary has some potential advantages: a single application is required; the insert is easily administered and can be removed as soon as labour starts or if complications ensue. Studies comparing the dinoprostone vaginal insert to other prostaglandin formulations have shown variable results, probably influenced by drug administration regimens, indications for induction, and cervical conditions of the women. The purpose of this study is to assess the efficacy of the induction of labour using dinoprostone in patients with an unfavourable cervix, and to compare the efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal dinoprostone gel.

Conditions

• Labor, Induced
• Cervical Ripening

Interventions

Type	Name	Description
DRUG	Dinoprostone vaginal pessary	10 mg controlled-release dinoprostone pessary applied for 24 hours
DRUG	Dinoprostone vaginal gel	2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-03-01
• Completion: 2008-06-01
• First posted: 2009-02-13
• Last updated: 2009-02-13

Locations

1 site across 1 country: Italy