Induction of LabourNCT04454346
Double Foley Catheter For Cervical Ripening
A study testing Double Foley Catheter For Ripening The Unfavorable Cervix in people with Induction of Labour, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the efficacy of three mechanical devices for pre-induction of labour cervical ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook cervical ripening balloon. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Induction of Labour
- What is being tested?
- Double Foley Catheter For Ripening The Unfavorable Cervix
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 15 Nov 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women with term pregnancy,
Who cannot join
- Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous uterine scars, estimated fetal weight above 4500
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital
Ankara, 06010
About this study
Official title: Double Foley Catheter For Ripening The Unfavorable Cervix: An Alternative Method
To compare the efficacy of three mechanical devices for pre-induction of labour cervical ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook cervical ripening balloon.
Read the detailed description
This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon catheter. Removal of the catheters is planned approximately 12 h after insertion if spontaneous expulsion occurred. The main outcome measures include changes in Bishop score, insertion to delivery time, mode of delivery and occurrence of adverse effects.
Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters are connected with sterile suture from the hole end and where the balloons borders end. Both catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by applying traction and full with 80 mL of normal saline. The cervix between two balloons of Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's similar to Cook balloon.
- Conditions
- Induction of Labour
- Being tested
- Double Foley Catheter For Ripening The Unfavorable Cervix
- Keywords
- Double Foley Catheter, Cook balloon, Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Foley Catheter For Ripening The Unfavorable CervixDevice
New method
| Study group | Role | What they receive |
|---|---|---|
| Double Foley Catheter | Experimental | The patients allocated to this arm were randomly and did not differ from the Single Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. The connected FCs were inserted into the cervix using long forceps and advanced to the internal os level. One of the Foley balloons was inflated with 80 ml of saline, and the other FC, now the cervicovaginal balloon, was pulled out with mild traction until the balloon could be visualized and inflated with 20 ml of saline. The vaginal speculum was removed, and the cervicovaginal balloon was inflated further to a total of 80 ml of saline. Both catheters were taped to the inner aspect of the thigh without tension Receives: Device: Double Foley Catheter For Ripening The Unfavorable Cervix |
| Single Foley Catheter | Experimental | The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. a 16-F FC was inserted into the cervix using long forceps. Then, the balloon was inflated with 80 ml of saline using a standard 20 ml syringe. The catheter was then pulled out until the balloon covered the internal os. The speculum was removed, and the catheter was fixed under slight tension to the inner aspect of the thigh Receives: Device: Double Foley Catheter For Ripening The Unfavorable Cervix |
| Cook Balloon | Experimental | The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Single Foley Catheter arm regard to patients' demographic features and characteristics. Cook cervical ripening group, the device was applied according to the manufacturer's instructions, and each balloon was inflated with 80 ml saline. The catheter was taped to the inner aspect of the thigh without tension. Receives: Device: Double Foley Catheter For Ripening The Unfavorable Cervix |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal delivery within 24 hours
the time from applying catheter to delivery
Measured: 24 hours
ripening success
Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score
Measured: 12 hours
pain score
The pain score during ripening phase which a visual analog scale is completed by the study population to assess the pain score during the entire ripening periods. The pain scores were assessed using the visual analog scale (where 0 = no pain and 10 = worst possible pain).
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start15 Jul 2020
- Primary completion1 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LabourStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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, Mehmet Obut, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Mehmet Obut, M.D, Study director, Etlik Zubeyde Hanim Woman Health's Care Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454346
- Sponsor's protocol ID
- 2020/06
- Status last verified
- Jan 2022
- First submitted
- 28 Jun 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Foley Catheter For Ripening The Unfavorable Cervix: An Alternative Method
- ClinicalTrials.gov ID
- NCT04454346
- Acronym / sponsor ID
- 2020/06
- Conditions
- Induction of Labour
- Keywords
- Double Foley Catheter, Cook balloon, Foley catheter
- Study type
- Interventional
- 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
- 15 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 1 Jul 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.
To compare the efficacy of three mechanical devices for pre-induction of labour cervical ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook cervical ripening balloon.
Detailed description
This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon catheter. Removal of the catheters is planned approximately 12 h after insertion if spontaneous expulsion occurred. The main outcome measures include changes in Bishop score, insertion to delivery time, mode of delivery and occurrence of adverse effects.
Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters are connected with sterile suture from the hole end and where the balloons borders end. Both catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by applying traction and full with 80 mL of normal saline. The cervix between two balloons of Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's similar to Cook balloon.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double Foley Catheter | Experimental | Device: Double Foley Catheter For Ripening The Unfavorable CervixThe patients allocated to this arm were randomly and did not differ from the Single Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. The connected FCs were inserted into the cervix using long forceps and advanced to the internal os level. One of the Foley balloons was inflated with 80 ml of saline, and the other FC, now the cervicovaginal balloon, was pulled out with mild traction until the balloon could be visualized and inflated with 20 ml of saline. The vaginal speculum was removed, and the cervicovaginal balloon was inflated further to a total of 80 ml of saline. Both catheters were taped to the inner aspect of the thigh without tension |
| Single Foley Catheter | Experimental | Device: Double Foley Catheter For Ripening The Unfavorable CervixThe patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. a 16-F FC was inserted into the cervix using long forceps. Then, the balloon was inflated with 80 ml of saline using a standard 20 ml syringe. The catheter was then pulled out until the balloon covered the internal os. The speculum was removed, and the catheter was fixed under slight tension to the inner aspect of the thigh |
| Cook Balloon | Experimental | Device: Double Foley Catheter For Ripening The Unfavorable CervixThe patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Single Foley Catheter arm regard to patients' demographic features and characteristics. Cook cervical ripening group, the device was applied according to the manufacturer's instructions, and each balloon was inflated with 80 ml saline. The catheter was taped to the inner aspect of the thigh without tension. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with term pregnancy,
Key exclusion criteria (1 listed)
- Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous uterine scars, estimated fetal weight above 4500
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 |
|---|---|---|
| Double Foley Catheter For Ripening The Unfavorable CervixNew method | Device | Cook Balloon, Double Foley Catheter, Single Foley Catheter |
Primary outcome
vaginal delivery within 24 hours
Time frame: 24 hours
the time from applying catheter to delivery
ripening success
Time frame: 12 hours
Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score
pain score
Time frame: 36 hours
The pain score during ripening phase which a visual analog scale is completed by the study population to assess the pain score during the entire ripening periods. The pain scores were assessed using the visual analog scale (where 0 = no pain and 10 = worst possible pain).
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 12 Jan 2022.
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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.
Mehmet Obut, M.D study director
Etlik Zubeyde Hanim Woman Health's Care Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Foley Catheter For Ripening The Unfavorable Cervix in people with Induction of Labour, 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 1 inclusion and 1 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 12 Jan 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?
vaginal delivery within 24 hours (time frame: 24 hours). 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?
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 12 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.