Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Cervical Ripening; Pregnancy, High-Risk
• Intervention / Treatment: Device: mechanical cervical ripening

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 222

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06000
    • University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women with unfavorable cervices and need to deliver for maternal or fetal health condition.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Foley catheter group; mechanical cervical ripening	Device: mechanical cervical ripening; mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon
Double-balloon group; mechanical cervical ripening	Device: mechanical cervical ripening; mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon
Cook cervical ripening balloon; mechanical cervical ripening	Device: mechanical cervical ripening; mechanical cervical ripening with a foley catheter or double-balloon catheter or Cook cervical ripening balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Publications and helpful links

General Publications

• 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].
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: mechanical cervical ripening

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No