Clincosm LogoSign in Get a demo

24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

Sponsor
Università degli Studi di Brescia (Other)
Overall Status
Completed
CT.gov ID
NCT00843362
Collaborator
(none)
133
Enrollment
1
Location
2
Arms
18
Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dinoprostone vaginal pessary
  • Drug: Dinoprostone vaginal gel
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

24-hours vaginal dinoprostone pessary

Drug: Dinoprostone vaginal pessary
10 mg controlled-release dinoprostone pessary applied for 24 hours
Other Names:
  • Propess, Ferring, Milan, Italy

    		•
    Active Comparator: 2

    Vaginal dinoprostone gel

    Drug: Dinoprostone vaginal gel
    2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval
    Other Names:
  • Prepidil, Pharmacia, Milan, Italy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. spontaneous vaginal delivery []

    Secondary Outcome Measures

    1. induction to labour time []

    2. induction to delivery time []

    3. rate of failed induction []

    4. cost per patient []

    5. rate of caesarean section for fetal heart rate abnormalities []

    6. 5 minute Apgar score < 7 []

    7. arterial cord blood pH <7.1 []

    8. uterine hyperstimulation []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynaecology, University of Brescia Brescia Italy 25123

    Sponsors and Collaborators

    • Università degli Studi di Brescia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00843362
    Other Study ID Numbers:
    • Spedali Civili 924
    First Posted:
    Feb 13, 2009
    Last Update Posted:
    Feb 13, 2009
    Last Verified:
    Feb 1, 2009
    Additional relevant MeSH terms:
    Dinoprostone

    Study Results

    No Results Posted as of Feb 13, 2009