24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

NCT00843362 | Completed Phase 4

• 1 other identifier: Spedali Civili 924
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• spontaneous vaginal delivery

Secondary Outcomes (8)

• induction to labour time

• induction to delivery time

• rate of failed induction

• cost per patient

• rate of caesarean section for fetal heart rate abnormalities

Study Arms (2)

1

EXPERIMENTAL

24-hours vaginal dinoprostone pessary

Drug: Dinoprostone vaginal pessary

2

ACTIVE COMPARATOR

Vaginal dinoprostone gel

Drug: Dinoprostone vaginal gel

Interventions

Dinoprostone vaginal pessary DRUG

10 mg controlled-release dinoprostone pessary applied for 24 hours

Also known as: Propess, Ferring, Milan, Italy

1

Dinoprostone vaginal gel DRUG

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

Also known as: Prepidil, Pharmacia, Milan, Italy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• singleton pregnancy, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks

You may not qualify if:

• premature rupture of the membranes, history of a previous caesarean section,
• maternal clinical contraindications to the administration of prostaglandins,
• fetal malpresentation

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, University of Brescia

Brescia, 25123, Italy

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: December 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 13, 2009

Record last verified: 2009-02

Locations

IT (1)