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Clinical Trials/NCT00843362
NCT00843362
Completed
Phase 4

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

Università degli Studi di Brescia1 site in 1 country133 target enrollmentDecember 2006

Overview

Phase
Phase 4
Intervention
Dinoprostone vaginal pessary
Conditions
Labor, Induced
Sponsor
Università degli Studi di Brescia
Enrollment
133
Locations
1
Primary Endpoint
spontaneous vaginal delivery
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
June 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Arms & Interventions

1

24-hours vaginal dinoprostone pessary

Intervention: Dinoprostone vaginal pessary

2

Vaginal dinoprostone gel

Intervention: Dinoprostone vaginal gel

Outcomes

Primary Outcomes

spontaneous vaginal delivery

Secondary Outcomes

  • 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

Study Sites (1)

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