- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03928600
Recruitment Status Active, not recruiting
First Posted April 26, 2019
Last update posted March 10, 2020
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-
|Experimental: Combined method induction group
25 micrograms misoprostol vaginal applied placed along with cervical Foley (team will repeat misoprostol application each 4 hours till 6 doses of misoprostol) After 4 hours of last misoprostol initiate oxytocin. Cervical Foley will be removed after 12h of placement or when fails out.
Combination Product: Cervical Foley combined with Misoprostol
Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug
|Placebo Comparator: Current department guidelines group
Following current department guidelines, as usual, with the method considered more suitable. If they opted for vaginal misoprostol, team will insert 25micrograms, repeat application 4/4h, until 150micrograms, after last misoprostol, wait 4 hours before initiating oxytocin. If option is vaginal dinoprostone the insert of 10mg is removed after 24h in place.
Drug: Dinoprostone 10mg insert OR
Application for 24h of Dinoprostone 10mg insert
Application of vaginal misoprostol 25ug 4/4h until 150ug
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- full-term (≥ 37 weeks of gestation)
- vertex-presenting gestations
- with no contraindication to vaginal delivery
- intact membranes
- Bishop score < 7 and cervical dilation ≤2 cm Exclusion Criteria: - contraindication for misoprostol - history of previous caesarean - rupture of membranes, - fetal or maternal morbidities (fetal major abnormalities, FIGO definition of pathological CTG, HELLP syndrome, preeclampsia or hypertension with severe features, fetal growth restriction)
Centro Hospitalar São João
Centro Hospitalar De São João, E.P.E.
Principal Investigator: Rita P Valente, MD Centro Hospitalar São João, Porto