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Completed

NCT Number: NCT00843362

24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics and Gynaecology, University of Brescia

Brescia, 25123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dinoprostone vaginal pessary

Drug

10 mg controlled-release dinoprostone pessary applied for 24 hours

Other names: Propess, Ferring, Milan, Italy

Dinoprostone vaginal gel

Drug

2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval

Other names: Prepidil, Pharmacia, Milan, Italy

Primary outcomes

  1. spontaneous vaginal delivery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2009
Registry last updated
Feb 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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