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Study was early terminated due to problems enrolling adequate number of patients
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This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone | Drug |
| ||
| Oxytocin |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal birth delivery within 24 hours and C-section rate | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure rate | 24 hours | |
| Uterine hyperstimulation and/or fetal distress | 24 hours | |
| Use of additional oxytocin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirão Preto | São Paulo | Brazil | |||
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|
| 24 hours |
| Hospital Municipal Universitário - Faculdade de Medicina do ABC |
| São Bernardo do Campo |
| São Paulo |
| Brazil |
| Hospital M Boi Mirim | São Paulo | São Paulo | Brazil |
| Hospital Maternidade Leonor Mendes de Barros | São Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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