24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

Phase 4

Completed

• Conditions: Labor, Induced; Cervical Ripening
• Interventions: Drug: Dinoprostone vaginal pessary; Drug: Dinoprostone vaginal gel

• Registration Number: NCT00843362
• Lead Sponsor: Università degli Studi di Brescia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Status Verified: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Last Update Submitted: 2009-02-12
• Study First Posted: 2009-02-13
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 133

Inclusion Criteria

• singleton pregnancy, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks

Exclusion Criteria

• premature rupture of the membranes, history of a previous caesarean section,
• maternal clinical contraindications to the administration of prostaglandins,
• fetal malpresentation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dinoprostone vaginal pessary	24-hours vaginal dinoprostone pessary
2	Dinoprostone vaginal gel	Vaginal dinoprostone gel

Primary Outcome Measures

Name	Time	Method
spontaneous vaginal delivery

Secondary Outcome Measures

Name	Time	Method
induction to labour time
induction to delivery time
rate of failed induction
cost per patient
rate of caesarean section for fetal heart rate abnormalities
5 minute Apgar score < 7
arterial cord blood pH <7.1
uterine hyperstimulation

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology, University of Brescia; 🇮🇹 Brescia, Italy