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Purpose:
To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.
Methods:
The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Active Comparator | Group of women allocated to misoprostol induction. |
|
| Dinoprostone | Active Comparator | Group of women allocated to dinoprostone induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol 25 mcg | Drug | To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful vaginal delivery within 24 hours | Percentage of women that achieve a vaginal delivery within 24 hours since induction process started | 24 hours since induction was started |
| Measure | Description | Time Frame |
|---|---|---|
| Successful cervical ripening within 24 hours | Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started | 24 hours since induction was started |
| Interval time from induction to delivery |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30723912 | Derived | De Bonrostro Torralba C, Tejero Cabrejas EL, Envid Lazaro BM, Franco Royo MJ, Roca Arquillue M, Campillos Maza JM. Low-dose vaginal misoprostol vs vaginal dinoprostone insert for induction of labor beyond 41st week: A randomized trial. Acta Obstet Gynecol Scand. 2019 Jul;98(7):913-919. doi: 10.1111/aogs.13556. Epub 2019 Feb 24. |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| Dinoprostone 10mg | Drug | To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor. |
|
|
Time passed since induction of labor started until delivery
| Hours passed between induction of labor until delivery within 72 hours |
| Need for a second induction | Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor | Assessed 24 hours since induction of labor was started |
| Vaginal delivery rate | Percentage of women that achieve vaginal delivery | Since labor induction had started until delivery had ocurred within 72 hours |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011458 | Prostaglandins E |