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24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

NCT00843362 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2009-02-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Università degli Studi di Brescia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-03-31
Completion
2008-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843362 on ClinicalTrials.gov