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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
372
hourly titrated misoprostol
Administration of 25 microgs every 6 hours, maximum 150 microgr
Vaginal delivery system of 10mg of dinoprostone
Araba University Hospital
Vitoria-Gasteiz, Basque Country, Spain
RECRUITINGCompare 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)
Time frame: 24 hours
The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group
Time frame: 12 hours
The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group
Time frame: 24 hours
The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group
Time frame: 12 hours
Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time frame: 24 hours
The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time frame: 24 hours
Compare the percentage of women requiring oxytocin in each group
Time frame: 24 hours
The percentage of women in each group having tachysystole
Time frame: 24 hours
Compare the number of women suffering from uterine rupture in each group
Time frame: 24 hours
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The percentage of women in each branch having uterine hypertonia
Time frame: 24 hours
Maternal morbility-mortality among pregnant participants
Time frame: up to 180 days
Compare fetal or neonatal morbility-mortality among the 3 groups
Time frame: up to 180 days