Cervical Ripening, Labor, Induced
Conditions
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.
Interventions
DRUGDinoprostone vaginal pessary
10 mg controlled-release dinoprostone pessary applied for 24 hours
2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| spontaneous vaginal delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| induction to delivery time | — |
| rate of failed induction | — |
| cost per patient | — |
| induction to labour time | — |
| 5 minute Apgar score < 7 | — |
| arterial cord blood pH <7.1 | — |
| uterine hyperstimulation | — |
| rate of caesarean section for fetal heart rate abnormalities | — |
Countries
Italy
Outcome results
None listed