Cervical RipeningNCT04687436
Foley Catheter Versus Double-balloon Catheter for Cervical Ripening
An observational study of Cervical Ripening and Pregnancy, High-Risk, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women. 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
- Cervical Ripening, Pregnancy, High-Risk
- What is being tested?
- mechanical cervical ripening
- Type of treatment
- Medical device
- How many people
- 222 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 30 Nov 2020
- 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 with unfavorable cervices and need to deliver for maternal or fetal health condition.
Who may be able to join
- Age between 18 and 40
- Singleton pregnancy
- Vertex presentation
- Bishop score <6
- Using a Foley catheter or cook balloon 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 (foreign national)
- Bishop score >6
- Being at active labor
- Multifetal pregnancy
- Non-vertex presentation
Show all 10Show fewer
- Scarred uterus (cesarean or myomectomy)
- Fetal structural or chromosomal anomaly
- Non-reassuring fetal cardiotocography before cervical ripening
- Regional anesthesia during the first stage
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: Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy
The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.
Read the detailed description
This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error.
The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score <6, using a foley catheter or cook balloon 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), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage.
The primary outcomes are the rate of bishop score >6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.
- Conditions
- Cervical Ripening, Pregnancy, High-Risk
- Being tested
- mechanical cervical ripening
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 with a foley catheter or double-balloon catheter or Cook cervical ripening balloon
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter group | mechanical cervical ripening Receives: Device: mechanical cervical ripening | |
| Double-balloon group | mechanical cervical ripening Receives: Device: mechanical cervical ripening | |
| Cook cervical ripening balloon | mechanical cervical ripening Receives: Device: mechanical cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
bishop score
bishop score >6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)
Measured: at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously
vaginal delivery rate
the difference in vaginal birth rate between groups
Measured: until the patient gives birth
vaginal delivery within 24 hours
the difference in vaginal delivery within 24 hours rate between groups
Measured: from the time of cervical ripening catheter insertion to the 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jul 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical RipeningStudies 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
- 222 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
- NCT04687436
- Sponsor's protocol ID
- mechanical cervical ripening
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2020
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28.
PubMed 19656148Sayed Ahmed WA, Ibrahim ZM, Ashor OE, Mohamed ML, Ahmed MR, Elshahat AM. Use of the Foley catheter versus a double balloon cervical ripening catheter in pre-induction cervical ripening in postdate primigravidae. J Obstet Gynaecol Res. 2016 Nov;42(11):1489-1494. doi: 10.1111/jog.13086. Epub 2016 Jul 19.
PubMed 27436681
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foley Catheter Versus Double-balloon Catheter for Cervical Ripening in Women With a High-risk Pregnancy
- ClinicalTrials.gov ID
- NCT04687436
- Acronym / sponsor ID
- mechanical cervical ripening
- Conditions
- Cervical Ripening, Pregnancy, High-Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 29 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.
The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.
Detailed description
This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error.
The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score <6, using a foley catheter or cook balloon 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), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage.
The primary outcomes are the rate of bishop score >6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foley catheter group | – | Device: mechanical cervical ripeningmechanical cervical ripening |
| Double-balloon group | – | Device: mechanical cervical ripeningmechanical cervical ripening |
| Cook cervical ripening balloon | – | Device: mechanical cervical ripeningmechanical cervical ripening |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with unfavorable cervices and need to deliver for maternal or fetal health condition.
Key inclusion criteria (6 listed)
- Age between 18 and 40
- Singleton pregnancy
- Vertex presentation
- Bishop score <6
- Using a Foley catheter or cook balloon for cervical ripening
Key exclusion criteria (10 listed)
- Being younger than 18 or over 40
- Communication problems (foreign national)
- 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 with a foley catheter or double-balloon catheter or Cook cervical ripening balloon | Device | Cook cervical ripening balloon, Double-balloon group, Foley catheter group |
Primary outcome
bishop score
Time frame: at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously
bishop score >6 is accepted as successful ripening. (max. 10, and the higher bishop score means better ripening has been occurred.)
vaginal delivery rate
Time frame: until the patient gives birth
the difference in vaginal birth rate between groups
vaginal delivery within 24 hours
Time frame: from the time of cervical ripening catheter insertion to the 24 hours
the difference in vaginal delivery within 24 hours rate between groups
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 7 Feb 2022.
- Background: PubMed 19656148Pennell CE, Henderson JJ, O'Neill MJ, McChlery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG. 2009 Oct;116(11):1443-52. doi: 10.1111/j.1471-0528.2009.02279.x. Epub 2009 Jul 28.
- Background: PubMed 27436681Sayed Ahmed WA, Ibrahim ZM, Ashor OE, Mohamed ML, Ahmed MR, Elshahat AM. Use of the Foley catheter versus a double balloon cervical ripening catheter in pre-induction cervical ripening in postdate primigravidae. J Obstet Gynaecol Res. 2016 Nov;42(11):1489-1494. doi: 10.1111/jog.13086. Epub 2016 Jul 19.
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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 Cervical Ripening and Pregnancy, High-Risk, 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 10 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 7 Feb 2022. 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?
bishop score (time frame: at the time of removing the cervical ripening catheter or when the balloon was expelled spontaneously). The study lists 3 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 NCT04687436, which also lists 2 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 7 Feb 2022.