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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04687436
Other study ID # mechanical cervical ripening
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date November 30, 2020

Study information

Verified date January 2022
Source Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error. The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score <6, using a foley catheter or cook balloon for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders). The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score >6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage. The primary outcomes are the rate of bishop score >6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.


Recruitment information / eligibility

Status Completed
Enrollment 222
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Age between 18 and 40 - Singleton pregnancy - Vertex presentation - Bishop score <6 - Using a Foley catheter or cook balloon for cervical ripening - High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders) Exclusion Criteria: - Being younger than 18 or over 40 - Communication problems (foreign national) - Bishop score >6 - Being at active labor - Multifetal pregnancy - Non-vertex presentation - Scarred uterus (cesarean or myomectomy) - Fetal structural or chromosomal anomaly - Non-reassuring fetal cardiotocography before cervical ripening - Regional anesthesia during the first stage

Study Design


Related Conditions & MeSH terms


Intervention

Device:
mechanical cervical ripening
mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon

Locations

Country Name City State
Turkey University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. Erratum in: BJOG. 2011 Mar;118(4):521. McCleery, S [corrected to McChlery, S]. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary vaginal delivery rate the difference in vaginal birth rate between groups until the patient gives birth
Primary 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
See also
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