Patient Satisfaction With Mechanical Cervical Ripening

Completed

• Conditions: Satisfaction, Patient

• Registration Number: NCT04683081
• Lead Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Primary Completion: 2021-03-17
• Study Completion: 2021-05-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital; 🇹🇷 Ankara, Turkey