24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

NCT ID: NCT00843362

Last Updated: 2009-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-06-30

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.

Conditions

Labor, Induced; Cervical Ripening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

24-hours vaginal dinoprostone pessary

Group Type: EXPERIMENTAL

Dinoprostone vaginal pessary

Intervention Type: DRUG

10 mg controlled-release dinoprostone pessary applied for 24 hours

2

Vaginal dinoprostone gel

Group Type: ACTIVE_COMPARATOR

Dinoprostone vaginal gel

Intervention Type: DRUG

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

Interventions

Dinoprostone vaginal pessary

10 mg controlled-release dinoprostone pessary applied for 24 hours

Intervention Type: DRUG

Dinoprostone vaginal gel

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

Intervention Type: DRUG

Other Intervention Names

Propess, Ferring, Milan, Italy; Prepidil, Pharmacia, Milan, Italy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

University of Brescia

Locations

Department of Obstetrics and Gynaecology, University of Brescia

Brescia, , Italy

Countries

Italy

Other Identifiers

Spedali Civili 924

Identifier Type: -

Identifier Source: org_study_id