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This study evaluates the efficacy and safety of the administration of oral misoprostol versus vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral misoprostol | Experimental | Administration of oral misoprostol according to a "3x1" diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment |
|
| Vaginal misoprostol | Active Comparator | vaginal misoprostol, 25 microgs every 4 hours |
|
| Vaginal dinoprostone | Active Comparator | vaginal dinoprostone, 10 mg during 24 hours (maximum) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral misoprostol | Drug | hourly titrated misoprostol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group | 12 hours | |
| The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oihane Lapuente Ocamica | Contact | OIHANE.LAPUENTEOCAMICA@osakidetza.eus | ||
| Amanda Lopez Picado | Contact | amanda.lopezpicado@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Oihane Lapuente Ocamica | OIHANE.LAPUENTEOCAMICA@osakidetza.eus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Araba University Hospital | Recruiting | Vitoria-Gasteiz | Basque Country | 01009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30621614 | Derived | Lapuente-Ocamica O, Ugarte L, Lopez-Picado A, Sanchez-Refoyo F, Lasa IL, Echevarria O, Alvarez-Sala J, Farinas A, Bilbao I, Barbero L, Vicarregui J, Hernanz Chaves R, Paz Corral D, Lopez-Lopez JA. Efficacy and safety of administering oral misoprostol by titration compared to vaginal misoprostol and dinoprostone for cervical ripening and induction of labour: study protocol for a randomised clinical trial. BMC Pregnancy Childbirth. 2019 Jan 8;19(1):14. doi: 10.1186/s12884-018-2132-3. |
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| Vaginal misoprostol |
| Drug |
Administration of 25 microgs every 6 hours, maximum 150 microgr |
|
| Vaginal dinoprostone | Drug | Vaginal delivery system of 10mg of dinoprostone |
|
| 24 hours |
| The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group | 12 hours |
| Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone) | 24 hours |
| The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone) | 24 hours |
| Compare the percentage of women requiring oxytocin in each group | 24 hours |
| The percentage of women in each group having tachysystole | 24 hours |
| Compare the number of women suffering from uterine rupture in each group | 24 hours |
| The percentage of women in each branch having uterine hypertonia | 24 hours |
| Maternal morbility-mortality among pregnant participants | up to 180 days |
| Compare fetal or neonatal morbility-mortality among the 3 groups | up to 180 days |
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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