24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

Università degli Studi di Brescia

Status and phase: Completed; Phase 4

Conditions: Labor, Induced; Cervical Ripening

Treatments: Drug: Dinoprostone vaginal gel; Drug: Dinoprostone vaginal pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT00843362

Spedali Civili 924

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

1

Experimental group

Description:

24-hours vaginal dinoprostone pessary

Treatment:

Drug: Dinoprostone vaginal pessary

2

Active Comparator group

Description:

Vaginal dinoprostone gel

Treatment:

Drug: Dinoprostone vaginal gel