Cervical RipeningNCT05253690
Comparing Methods for Balloon Catheter Inserting: View Guided (Speculum) Versus Manual Guided at Cervical Examination
A study testing balloon catheter insertion approach for labor induction in people with Cervical Ripening, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Induction of labor is a common obstetric procedure. Foley catheter is recommended by WHO for cervical ripening. Insertion is typically speculum guided but digital insertion has been reported to be faster, better tolerated and with similar insertion success rate compared to speculum guided insertion in a mixed… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening
- What is being tested?
- balloon catheter insertion approach for labor induction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jan 2022to 10 Jan 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singelton parous women Term pregnancy Vertex position
- -
Who cannot join
- Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Galil Medical Center
Nahariya
Maya Wolf, MD, 972-507887800, homesickid@yahoo.com
About this study
Official title: Comparing Two Methods for Inserting a Balloon Catheter : View-guided Approach Using a Speculum Versus Manual Guided Approach at Cervical Examination - a Prospective Randomized Trail
Induction of labor is a common obstetric procedure. Foley catheter is recommended by WHO for cervical ripening. Insertion is typically speculum guided but digital insertion has been reported to be faster, better tolerated and with similar insertion success rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluated the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score<6.
Read the detailed description
Globally, there has been an increase in birth-induced labor from 9.5% to 29% in the last 3 decades. Circumstances requiring induction include gestational age of 41 weeks or more, hypertension, fetal growth disorder, gestational diabetes and others.
There are different methods of induction, the choice of the best method depends on the bishop score, an estimate based on cervical related data like opening (cm), deletion (%) and other parameters, also the choice of induction method depends on the obstetric history of the mother. Bishop score less than 6, indicates an immature cervix, and therefore increases the chance of induction failure.
The mechanism by which the catheter works includes a mechanical effect that causes the cervix to dilate, but in addition the direct stress on the inner surface of the cervix tissue and lower segment of the uterus indirectly causes local secretion of prostoglandins which help softening the cervix and may induce contractions.
Inserting a single or double balloon catheter, is traditionally performed in a lithotomy position, and after inserting a speculum, disinfecting with polydine, identifying the external os of the cervix and then inserting the catheter, inflating the balloon with saline up to 30-80 ml while looking at the position of the balloon.
Insertion of the catheter is typically speculum guided, but digital insertion has been reported to be faster, better tolerated and with similar insertion success and infections rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluate the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score<6.
Methods: A randomized trial. Participants are parous at term with unripe cervixes (Bishop Score ≤ 6) admitted for induction of labor. They will be randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position (1:1, 50 in each group). Primary outcomes are pain score [VAS] and time to birth. Secondary outcomes are procedure duration, maternal satisfaction, success and bishop score change.
- Conditions
- Cervical Ripening
- Being tested
- balloon catheter insertion approach for labor induction
- Keywords
- labor induction, balloon catheter, cervical ripenning, speculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon catheter insertion approach for labor inductionProcedure or surgery
Parous women will be randomized to labor induction by view-guided approach using a speculum for catheter insersion versus manual guided catheter balloon insersion at cervical examination
| Study group | Role | What they receive |
|---|---|---|
| speculum guided | Active comparator | view-guided approach using a speculum Receives: Procedure: balloon catheter insertion approach for labor induction |
| manual guided | Experimental | manual guided approach at cervical examination Receives: Procedure: balloon catheter insertion approach for labor induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal pain sensation during the procedure
VAS (visual analog scale) SCORE scale 0-10 0-better outcome 10-worse outcome
Measured: during the procedure
induction to delivery duration
hours
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
catheter insertion duration
minutes
Measured: during the procedure
maternal satisfaction- questionnaire
questionnaire including 5 questions about maternal preference for catheter insertion methods
Measured: during one hour after the procedure
chorioamnionitis- fever during labor
clinical diagnosis
Measured: during labor up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start10 Jan 2022
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Maya Wolf, Western Galilee Hospital-Nahariya
- Investigators
- Maya Wolf, MD, Study director, Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253690
- Sponsor's protocol ID
- 0150-21-NHR
- Status last verified
- Mar 2022
- First submitted
- 19 Jan 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jonsson M, Hellgren C, Wiberg-Itzel E, Akerud H. Assessment of pain in women randomly allocated to speculum or digital insertion of the Foley catheter for induction of labor. Acta Obstet Gynecol Scand. 2011 Sep;90(9):997-1004. doi: 10.1111/j.1600-0412.2011.01197.x. Epub 2011 Jun 27.
PubMed 21615714Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, Abdelwahab M, Vaughn M, Marshall K, Prasad N, Soulsby-Monroy R, Saade GR, Saad AF. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):139-145. doi: 10.1097/AOG.0000000000004182.
PubMed 33278290Chia HM, Tan PC, Tan SP, Hamdan M, Omar SZ. Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial. BMC Pregnancy Childbirth. 2020 May 29;20(1):330. doi: 10.1186/s12884-020-03029-0.
PubMed 32471369Liu X, Wang Y, Zhang F, Zhong X, Ou R, Luo X, Qi H. Double- versus single-balloon catheters for labour induction and cervical ripening: a meta-analysis. BMC Pregnancy Childbirth. 2019 Oct 16;19(1):358. doi: 10.1186/s12884-019-2491-4.
PubMed 31619189de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
PubMed 31623014Abu Shqara R, Nakhleh Francis Y, Haj H, Markdorf S, Lowenstein L, Frank Wolf M. Digital vs speculum-guided catheter balloon insertion for cervical ripening in multiparas: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100943. doi: 10.1016/j.ajogmf.2023.100943. Epub 2023 Mar 25.
PubMed 36972835
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Methods for Inserting a Balloon Catheter : View-guided Approach Using a Speculum Versus Manual Guided Approach at Cervical Examination - a Prospective Randomized Trail
- ClinicalTrials.gov ID
- NCT05253690
- Acronym / sponsor ID
- 0150-21-NHR
- Conditions
- Cervical Ripening
- Keywords
- labor induction, balloon catheter, cervical ripenning, speculum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 24 Feb 2022 (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.
Induction of labor is a common obstetric procedure. Foley catheter is recommended by WHO for cervical ripening. Insertion is typically speculum guided but digital insertion has been reported to be faster, better tolerated and with similar insertion success rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluated the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score<6.
Detailed description
Globally, there has been an increase in birth-induced labor from 9.5% to 29% in the last 3 decades. Circumstances requiring induction include gestational age of 41 weeks or more, hypertension, fetal growth disorder, gestational diabetes and others.
There are different methods of induction, the choice of the best method depends on the bishop score, an estimate based on cervical related data like opening (cm), deletion (%) and other parameters, also the choice of induction method depends on the obstetric history of the mother. Bishop score less than 6, indicates an immature cervix, and therefore increases the chance of induction failure.
The mechanism by which the catheter works includes a mechanical effect that causes the cervix to dilate, but in addition the direct stress on the inner surface of the cervix tissue and lower segment of the uterus indirectly causes local secretion of prostoglandins which help softening the cervix and may induce contractions.
Inserting a single or double balloon catheter, is traditionally performed in a lithotomy position, and after inserting a speculum, disinfecting with polydine, identifying the external os of the cervix and then inserting the catheter, inflating the balloon with saline up to 30-80 ml while looking at the position of the balloon.
Insertion of the catheter is typically speculum guided, but digital insertion has been reported to be faster, better tolerated and with similar insertion success and infections rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluate the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score<6.
Methods: A randomized trial. Participants are parous at term with unripe cervixes (Bishop Score ≤ 6) admitted for induction of labor. They will be randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position (1:1, 50 in each group). Primary outcomes are pain score [VAS] and time to birth. Secondary outcomes are procedure duration, maternal satisfaction, success and bishop score change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| speculum guided | Active comparator | Procedure: balloon catheter insertion approach for labor inductionview-guided approach using a speculum |
| manual guided | Experimental | Procedure: balloon catheter insertion approach for labor inductionmanual guided approach at cervical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Singelton parous women Term pregnancy Vertex position
- -
Key exclusion criteria (1 listed)
- Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly
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 |
|---|---|---|
| balloon catheter insertion approach for labor inductionParous women will be randomized to labor induction by view-guided approach using a speculum for catheter insersion versus manual guided catheter balloon insersion at cervical examination | Procedure or surgery | manual guided, speculum guided |
Primary outcome
Maternal pain sensation during the procedure
Time frame: during the procedure
VAS (visual analog scale) SCORE scale 0-10 0-better outcome 10-worse outcome
induction to delivery duration
Time frame: through study completion, an average of 1 year
hours
3 secondary outcomes
catheter insertion duration
Time frame: during the procedure
maternal satisfaction- questionnaire
Time frame: during one hour after the procedure
chorioamnionitis- fever during labor
Time frame: during labor up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 21615714Jonsson M, Hellgren C, Wiberg-Itzel E, Akerud H. Assessment of pain in women randomly allocated to speculum or digital insertion of the Foley catheter for induction of labor. Acta Obstet Gynecol Scand. 2011 Sep;90(9):997-1004. doi: 10.1111/j.1600-0412.2011.01197.x. Epub 2011 Jun 27.
- Background: PubMed 33278290Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, Abdelwahab M, Vaughn M, Marshall K, Prasad N, Soulsby-Monroy R, Saade GR, Saad AF. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):139-145. doi: 10.1097/AOG.0000000000004182.
- Background: PubMed 32471369Chia HM, Tan PC, Tan SP, Hamdan M, Omar SZ. Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial. BMC Pregnancy Childbirth. 2020 May 29;20(1):330. doi: 10.1186/s12884-020-03029-0.
- Background: PubMed 31619189Liu X, Wang Y, Zhang F, Zhong X, Ou R, Luo X, Qi H. Double- versus single-balloon catheters for labour induction and cervical ripening: a meta-analysis. BMC Pregnancy Childbirth. 2019 Oct 16;19(1):358. doi: 10.1186/s12884-019-2491-4.
- Background: PubMed 31623014de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
- Derived from this study: PubMed 36972835Abu Shqara R, Nakhleh Francis Y, Haj H, Markdorf S, Lowenstein L, Frank Wolf M. Digital vs speculum-guided catheter balloon insertion for cervical ripening in multiparas: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100943. doi: 10.1016/j.ajogmf.2023.100943. Epub 2023 Mar 25.
- Individual participant dataSharing planned: No
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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.
Maya Wolf, MD study director
Galilee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon catheter insertion approach for labor induction in people with Cervical Ripening, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Wolf, MD (972-50-7887800, mayaw@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal pain sensation during the procedure (time frame: during the procedure). 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 NCT05253690, which also lists 6 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 1 Apr 2022.