Patient Satisfaction With Mechanical Cervical Ripening

Cervical Ripening: a Comparison of Three Mechanical Methods in Term of Patient Satisfaction

In this study, we aimed to compare three mechanical methods such as foley catheter, cook balloon catheter and modified double-balloon Foley catheter for cervical ripening in terms of patient satisfaction

Study Overview

• Status: Completed
• Conditions: Satisfaction, Patient
• Intervention / Treatment: Device: mechanical cervical ripening

Detailed Description

This is a prospective observational study. The planned sample size is 34 pregnant women per group with 90% power and 0.05 alpha error.

VAS score systems and Salmon's item list were used to evaluate the satisfaction level.

The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score <6, using a foley catheter cook balloon catheter or modified double-balloon Foley catheter 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), known fetal structural or chromosomal anomaly, presence of non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage, operative delivery, presence of maternal, fetal or neonatal complication.

The primary outcomes are the differences in satisfaction level between methods with using either the VAS score system or Salmon's item list and pain scores.

The secondary outcomes are the effects of giving birth within 24 hours, parity status, the length of the first stage of labor education level and cesarean section due to failed induction on the satisfaction level.

• Study Type: Observational
• Enrollment (Actual): 34

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

• Sampling Method: Probability Sample

Study Population

Pregnant women who were applied one of the mechanical cervical ripening methods, Foley catheter, Cook balloon catheter or modified double-balloon Foley catheter

Description

Inclusion Criteria:

• Age between 18 and 40
• Singleton pregnancy
• Vertex presentation
• Bishop score <6
• Using a Foley catheter cook balloon catheter or modified double-balloon Foley catheter 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
• Bishop score >6
• Being at active labor
• Multifetal pregnancy
• Non-vertex presentation
• Scarred uterus (cesarean or myomectomy)
• Known fetal structural or chromosomal anomaly
• Presence of non-reassuring fetal cardiotocography before cervical ripening
• Regional anesthesia during the first stage
• Operative delivery
• Presence of maternal, fetal or neonatal complication.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Foley catheter group; pregnant women who were applied Foley catheter for cervical ripening	Device: mechanical cervical ripening; mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
Cook balloon catheter group; pregnant women who were applied Cook balloon catheter for cervical ripening	Device: mechanical cervical ripening; mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
Modified double-balloon Foley catheter group; pregnant women who were applied modified double-balloon Foley catheter for cervical ripening	Device: mechanical cervical ripening; mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction level	Overall patient satisfaction score is obteined by VAS score system and Salmon's items list	within the first 24 hours after birth
Pain scores	Pain scores are obteined by VAS score system	immediately after application

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lim SE, Tan TL, Ng GYH, Tagore S, Kyaw EEP, Yeo GSH. Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial. Singapore Med J. 2018 Aug;59(8):419-424. doi: 10.11622/smedj.2018097.
• Akca A, Corbacioglu Esmer A, Ozyurek ES, Aydin A, Korkmaz N, Gorgen H, Akbayir O. The influence of the systematic birth preparation program on childbirth satisfaction. Arch Gynecol Obstet. 2017 May;295(5):1127-1133. doi: 10.1007/s00404-017-4345-5. Epub 2017 Mar 16.
• Tomlinson AJ, Archer PA, Hobson S. Induction of labour: a comparison of two methods with particular concern to patient acceptability. J Obstet Gynaecol. 2001 May;21(3):239-41. doi: 10.1080/01443610120046314.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 17, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: patient satisfaction

Drug and device information, study documents

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