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Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction.
Opposite to old studies of cervical ripening, some recent studies have shown promise in reducing labor time and risk of cesarean delivery with combination methods. The effectiveness of this procedure is of major clinical importance and has a large impact in our quotidian practice.
The objective is to compare the effectiveness of a combined new method to current guidelines of our department
We designed a randomized trial that will compare two groups: misoprostol-cervical Foley simultaneously and the current department guidelines (misoprostol alone/dinoprostone alone).
Inclusion criteria: full-term (≥ 37 weeks of gestation), singleton, vertex-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined method induction group | Experimental |
|
|
| Current department guidelines group | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Foley combined with Misoprostol | Combination Product | Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to delivery | Time to delivery | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| cesarean delivery rate | cesarean delivery rate | 3 days |
| time to active labor | defined as dilation of 6 cm or greater | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita P Valente, MD | Centro Hospitalar São João, Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar São João | Porto | 4100 | Portugal |
Study Protocol, Informed Consent Form, Statistical Analysis Plan
no ending
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D015232 | Dinoprostone |
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Dinoprostone 10mg insert OR | Drug | Application for 24h of Dinoprostone 10mg insert |
|
| Misoprostol | Drug | Application of vaginal misoprostol 25ug 4/4h until 150ug |
|
| rate of delivery within 12 hours | rate of delivery within 12 hours | 12 hours |
| rate of delivery within 24 hours | rate of delivery within 24 hours | 24 hours |
| mean of maternal length of stay | induction to discharge | average 3 days |
| indication for cesarean delivery | indication for cesarean delivery | 3 days |
| composite maternal morbidity outcome | third- or fourth-degree perineal laceration, blood transfusion, chorioamnionitis, endometritis, wound infection, venous thromboembolism, hysterectomy, intensive care unit admission or death. | 6 weeks |
| composite of neonatal morbidities | SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV | 30 days |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011458 | Prostaglandins E |
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |