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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 24-hours vaginal dinoprostone pessary |
|
| 2 | Active Comparator | Vaginal dinoprostone gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone vaginal pessary | Drug | 10 mg controlled-release dinoprostone pessary applied for 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| spontaneous vaginal delivery |
| Measure | Description | Time Frame |
|---|---|---|
| induction to labour time | ||
| induction to delivery time | ||
| rate of failed induction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynaecology, University of Brescia | Brescia | 25123 | Italy |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Dinoprostone vaginal gel | Drug | 2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval |
|
|
| cost per patient |
| rate of caesarean section for fetal heart rate abnormalities |
| 5 minute Apgar score < 7 |
| arterial cord blood pH <7.1 |
| uterine hyperstimulation |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |