A Phase 4 interventional study of Misoprostol 25 mcg and Dinoprostone 10mg in Induced Labor, Cervical Ripening and Obstetric Labor, sponsored by Hospital Miguel Servet. Completed. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Hospital Miguel Servet · Phase 4, Interventional, and Treatment
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.
Hospital Miguel Servet is the lead sponsor of 25 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group of women allocated to misoprostol induction.
Drug: Misoprostol 25 mcg
Group of women allocated to dinoprostone induction.
Drug: Dinoprostone 10mg
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
Also known as: Misoprostol induction
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
Also known as: Dinoprostone induction
Successful vaginal delivery within 24 hours
Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
Time frame: 24 hours since induction was started
Successful cervical ripening within 24 hours
Percentage of women that achieve Bishop score \> 6 within 24 hours since induction process started
Time frame: 24 hours since induction was started
Interval time from induction to delivery
Time passed since induction of labor started until delivery
Time frame: 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
Time frame: Assessed 24 hours since induction of labor was started
Vaginal delivery rate
Percentage of women that achieve vaginal delivery
Time frame: Since labor induction had started until delivery had ocurred within 72 hours
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Hospital Miguel Servet