Satisfaction, PatientNCT04683081
Patient Satisfaction With Mechanical Cervical Ripening
An observational study of Satisfaction, Patient, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Patient
- What is being tested?
- mechanical cervical ripening
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 20 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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).
Who cannot join
- Being younger than 18 or over 40
- Communication problems
- Bishop score >6
- Being at active labor
- Multifetal pregnancy
- Non-vertex presentation
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
Ankara, 06000
About this study
Official title: 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
Read the 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.
- Conditions
- Satisfaction, Patient
- Being tested
- mechanical cervical ripening
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical cervical ripeningDevice
mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter group | pregnant women who were applied Foley catheter for cervical ripening Receives: Device: mechanical cervical ripening | |
| Cook balloon catheter group | pregnant women who were applied Cook balloon catheter for cervical ripening Receives: Device: mechanical cervical ripening | |
| Modified double-balloon Foley catheter group | pregnant women who were applied modified double-balloon Foley catheter for cervical ripening Receives: Device: mechanical cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction level
Overall patient satisfaction score is obteined by VAS score system and Salmon's items list
Measured: within the first 24 hours after birth
Pain scores
Pain scores are obteined by VAS score system
Measured: immediately after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Mar 2020
- Primary completion17 Mar 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Satisfaction, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal Sarsmaz, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683081
- Sponsor's protocol ID
- patient satisfaction
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2020
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30175373Tomlinson 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.
PubMed 12521850Akca 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.
PubMed 28303340
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening: a Comparison of Three Mechanical Methods in Term of Patient Satisfaction
- ClinicalTrials.gov ID
- NCT04683081
- Acronym / sponsor ID
- patient satisfaction
- Conditions
- Satisfaction, Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foley catheter group | – | Device: mechanical cervical ripeningpregnant women who were applied Foley catheter for cervical ripening |
| Cook balloon catheter group | – | Device: mechanical cervical ripeningpregnant women who were applied Cook balloon catheter for cervical ripening |
| Modified double-balloon Foley catheter group | – | Device: mechanical cervical ripeningpregnant women who were applied modified double-balloon Foley catheter for cervical ripening |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Being younger than 18 or over 40
- Communication problems
- Bishop score >6
- Being at active labor
- Multifetal pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical cervical ripeningmechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery | Device | Cook balloon catheter group, Foley catheter group, Modified double-balloon Foley catheter group |
Primary outcome
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
Pain scores
Time frame: immediately after application
Pain scores are obteined by VAS score system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 30175373Lim 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.
- Background: PubMed 12521850Tomlinson 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.
- Background: PubMed 28303340Akca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, Patient, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction level (time frame: within the first 24 hours after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.