24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

Cervical Ripening Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843362
• Other study ID #: Spedali Civili 924
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2009
• Last updated: February 12, 2009
• Start date: December 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Labor, Induced

Intervention

Drug:
• Dinoprostone vaginal pessary
10 mg controlled-release dinoprostone pessary applied for 24 hours
• Dinoprostone vaginal gel
2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval

Locations

Country	Name	City	State
Italy	Department of Obstetrics and Gynaecology, University of Brescia	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spontaneous vaginal delivery			No
Secondary	induction to labour time			No
Secondary	induction to delivery time			No
Secondary	rate of failed induction			No
Secondary	cost per patient			No
Secondary	rate of caesarean section for fetal heart rate abnormalities			Yes
Secondary	5 minute Apgar score < 7			Yes
Secondary	arterial cord blood pH <7.1			Yes
Secondary	uterine hyperstimulation			Yes