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Completed

NCT Number: NCT04683081

Patient Satisfaction With Mechanical Cervical Ripening

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical cervical ripening

Device

mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery

Primary outcomes

  1. Patient satisfaction level

    Time frame: within the first 24 hours after birth

    Overall patient satisfaction score is obteined by VAS score system and Salmon's items list

  2. Pain scores

    Time frame: immediately after application

    Pain scores are obteined by VAS score system

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2020
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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