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Comparing Combined Foley Catheter Balloon and PGE2 Vaginal Ovule With Early Amniotomy and PGE2 for Induction of Labor at Term: A Randomized Study
This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.
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. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.
Age
18 - 40 years
Sex
FEMALE
Healthy Volunteers
Yes
Zeynep Kamil Education and Research Hospital
Istanbul, Uskudar, Turkey (Türkiye)
Start Date
August 15, 2018
Primary Completion Date
September 15, 2019
Completion Date
October 1, 2019
Last Updated
February 4, 2021
250
ACTUAL participants
early amniotomy
PROCEDURE
foley catheter balloon placement
DEVICE
Lead Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Data Source & Attribution
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