NCT04687436|Completed
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Sponsor study identifier
observational
222
1 country
1
Study Start
July 1, 2020
Actual (reported)Primary Completion
November 30, 2020
Actual (reported)Study Completion
November 30, 2020
Actual (reported)The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2020
Actual (reported)November 30, 2020
Actual (reported)November 30, 2020
Actual (reported)December 21, 2020
Actual (reported)December 29, 2020
Actual (reported)bishop score
bishop score \>6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)
at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously
vaginal delivery rate
the difference in vaginal birth rate between groups
until the patient gives birth
vaginal delivery within 24 hours
the difference in vaginal delivery within 24 hours rate between groups
from the time of cervical ripening catheter insertion to the 24 hours
mechanical cervical ripening
mechanical cervical ripening
mechanical cervical ripening
mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pregnant women with unfavorable cervices and need to deliver for maternal or fetal health condition.
University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
Ankara, 06000, Turkey (Türkiye)
Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28.
Sayed Ahmed WA, Ibrahim ZM, Ashor OE, Mohamed ML, Ahmed MR, Elshahat AM. Use of the Foley catheter versus a double balloon cervical ripening catheter in pre-induction cervical ripening in postdate primigravidae. J Obstet Gynaecol Res. 2016 Nov;42(11):1489-1494. doi: 10.1111/jog.13086. Epub 2016 Jul 19.
222 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2020
First Posted
December 29, 2020
Study Start
July 1, 2020
Actual (reported)Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening
Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy
Contact the study team to confirm eligibility.
Primary Completion
November 30, 2020
Actual (reported)Study Completion
November 30, 2020
Actual (reported)Last Updated
February 7, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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