- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00843362
24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction
February 12, 2009 updated by: Università degli Studi di Brescia
A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brescia, Italy, 25123
- Department of Obstetrics and Gynaecology, University of Brescia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
24-hours vaginal dinoprostone pessary
|
10 mg controlled-release dinoprostone pessary applied for 24 hours
Other Names:
|
Active Comparator: 2
Vaginal dinoprostone gel
|
2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
spontaneous vaginal delivery
|
Secondary Outcome Measures
Outcome Measure |
---|
uterine hyperstimulation
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
February 12, 2009
First Submitted That Met QC Criteria
February 12, 2009
First Posted (Estimate)
February 13, 2009
Study Record Updates
Last Update Posted (Estimate)
February 13, 2009
Last Update Submitted That Met QC Criteria
February 12, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spedali Civili 924
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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