A Phase 2 interventional study of Foley catheter and PGE2 in Unfavorable Cervix, Cervical Ripening, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-01.
Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Phase 2, Interventional, and Treatment
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.
An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter.
Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix
Device: Foley catheter · Drug: PGE2
10 mg PGE2 vaginal ovule will be inserted to the posterior fornix
Drug: PGE2
An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.
10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.
Also known as: propess
induction-to- delivery time
the length of time between the beginning of induction and the end of labor
Time frame: the length of time between the beginning of induction and the end of labor
induction-to-active phase of labor time
the length of time between the beginning of induction and the onset of labor
Time frame: the length of time between the beginning of induction and the onset of labor
Plan to share: Undecided
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Zeynep Kamil Maternity and Pediatric Research and Training Hospital