NCT04683081

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

December 21, 2020

Last Update Submit

February 25, 2025

Conditions

Satisfaction, Patient

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Foley catheter group

pregnant women who were applied Foley catheter for cervical ripening

Device: mechanical cervical ripening

Cook balloon catheter group

pregnant women who were applied Cook balloon catheter for cervical ripening

Device: mechanical cervical ripening

Modified double-balloon Foley catheter group

pregnant women who were applied modified double-balloon Foley catheter for cervical ripening

Device: mechanical cervical ripening

Interventions

mechanical cervical ripeningDEVICE

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

Cook balloon catheter groupFoley catheter groupModified double-balloon Foley catheter group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 30175373BACKGROUND

  • 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.

    PMID: 12521850BACKGROUND

  • 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.

    PMID: 28303340BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

March 1, 2020

Primary Completion

March 17, 2021

Study Completion

May 20, 2021

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations

TU(1)