24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

This study has been completed.
Sponsor:
Information provided by:
Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT00843362
First received: February 12, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
Labor, Induced
Cervical Ripening
Drug: Dinoprostone vaginal pessary
Drug: Dinoprostone vaginal gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • spontaneous vaginal delivery [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • induction to labour time [ Designated as safety issue: No ]
  • induction to delivery time [ Designated as safety issue: No ]
  • rate of failed induction [ Designated as safety issue: No ]
  • cost per patient [ Designated as safety issue: No ]
  • rate of caesarean section for fetal heart rate abnormalities [ Designated as safety issue: Yes ]
  • 5 minute Apgar score < 7 [ Designated as safety issue: Yes ]
  • arterial cord blood pH <7.1 [ Designated as safety issue: Yes ]
  • uterine hyperstimulation [ Designated as safety issue: Yes ]

Enrollment: 133
Study Start Date: December 2006
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843362

Locations
Italy
Department of Obstetrics and Gynaecology, University of Brescia
Brescia, Italy, 25123
Sponsors and Collaborators
Università degli Studi di Brescia
  More Information

No publications provided

Responsible Party: Tiziana Frusca, University of Brescia
ClinicalTrials.gov Identifier: NCT00843362     History of Changes
Other Study ID Numbers: Spedali Civili 924
Study First Received: February 12, 2009
Last Updated: February 12, 2009
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014