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24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843362
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : February 13, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Labor, Induced Cervical Ripening Drug: Dinoprostone vaginal pessary Drug: Dinoprostone vaginal gel Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : December 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Prepidil, Pharmacia, Milan, Italy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843362

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Department of Obstetrics and Gynaecology, University of Brescia
Brescia, Italy, 25123
Sponsors and Collaborators
Università degli Studi di Brescia
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Responsible Party: Tiziana Frusca, University of Brescia Identifier: NCT00843362    
Other Study ID Numbers: Spedali Civili 924
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Reproductive Control Agents
Physiological Effects of Drugs