Labor, InducedPhase 4TOLERANCENCT07288021
Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
A Phase 4 study testing Topical Analgesia with Lidocaine-Prilocaine cream in people with Labor, Induced, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Topical Analgesia with Lidocaine-Prilocaine cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Feb 2024to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women scheduled for labor induction with balloon catheter.
- 18 years of age or older.
- Singleton pregnancy with a cephalic presentation.
- ≥ 34 completed gestational weeks.
- Does not participate in any other trial that might affect maternal or fetal/neonatal outcomes.
- No contraindication for vaginal delivery
Who cannot join
- Unable or unwilling to provide and sign informed consent forms.
- Known sensitivity to EMLA or placebo substance.
- Known vulvodynia or vaginismus - rendering vaginal examination not possible.
- Any chronic pain syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 3339419
Dafna Ben Yehuda Raz, MD, +97248359366, dafna.ben-yehuda@b-zion.org.il
Dafna Ben Yehuda Raz, MD, OBGYN resident
About this study
The goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals.
All participants are 18 or older, carrying a singleton in vertex position and in need of labor induction, are late-preterm or term (34 weeks gestation and onward) and without contraindication to vaginal delivery.
Investigators seek to compare pain levels and patient satisfaction between two groups:
Nulliparous patients, using EMLA or placebo (randomized, double blinded). Multiparous patients, EMLA or placebo.
- Conditions
- Labor, Induced
- Being tested
- Topical Analgesia with Lidocaine-Prilocaine cream, Placebo
- Keywords
- induction, balloon catheter, EMLA, Lidocaine/prilocaine, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Analgesia with Lidocaine-Prilocaine creamDrug
patients allocated to \'EMLA\' arm will receive topical analgesia cream prior to speculum insertion, as part of the administration of balloon catheter insertion process.
3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made to allow for maximal analgesic affect.
PlaceboOther
patients allocated to \'Placebo\' arm will receive lubrication with placebo cream prior to speculum insertion, as part of the administration of balloon catheter insertion process.
3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made.
| Study group | Role | What they receive |
|---|---|---|
| EMLA | Experimental | Not described Receives: Drug: Topical Analgesia with Lidocaine-Prilocaine cream |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels during insertion
Pain levels during insertion of balloon catheter, as experienced by participant and ranked from 1 to 5 [1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)].
Measured: directly after application and insertion of balloon catheter.
Secondary outcomes (13)
analgesia while with balloon catheter
need for medical analgetics while with balloon catheter, to be checked by analgetics given by nursing staff while the patient is with the balloon cathether in place - a dichotomic variable (yes/no).
Measured: 6-12 hours
pain score during removal of catheter
Pain levels during removal of balloon catheter, as experienced by participant and ranked from 1 to 5 [1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)].
Measured: to be asked directly after removal, on a scale of 1-5.
willingness to undergo cervical ripening with balloon catheter in the future
willingness to undergo cervical ripening with balloon catheter in the future, on a scale of 1-5 (1- no, not under any circumstances; 2 - only if no other option exists; 3 - ambivalent; 4 - yes, but with concern; 5 - yes, no problem).
Measured: to be asked directly after removal, on a scale of 1-5.
analgesia during delivery
need and use for medical analgetics during the delivery process, including epidural, dolestion and NO.
Measured: From time of balloon insertion until the time of delivery, assessed up to 3 days and to be checked immediately after delivery.
mode of delivery
mode of delivery - vaginal, operative vaginal of cesarean delivery
Measured: at delivery
neonatal weight
neonatal weight in grams and percentile according to birth weight curves
Measured: immediately after delivery
APGAR [Appearance (color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing)] score
APGAR scores at 1, 5 and 10 minutes of life of newborn, as given by midwife/doctor present at the time. higher values on this score reflect a better outcome.
Measured: up to 10 minutes after delivery
cord blood gas
cord blood gas levels, the first measurement taken after birth and up to 10 minutes after delivery.
Measured: up to 10 minutes after delivery
Neonatal Intensive Care Unit (NICU) admission
NICU admission of newborn within first week of life
Measured: from delivery and up to 1 week
neonatal infection
neonatal infection or suspicion of during birth hospitalization
Measured: 1st week after delivery
duration of insertion procedure
duration of insertion of catheter procedure
Measured: balloon insertion duration, estimated as up to 20 minutes
difficulty of insertion
difficulty of insertion of catheter, as described by inserting physician
Measured: to be reported by inserting doctor immediately after insertion procedure is completed, estimated up to 20 minutes.
obstetric trauma
presence of, and degree, of perineal lacerations
Measured: up to an hour after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start5 Feb 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288021
- Sponsor's protocol ID
- 0061-23-BNZ
- Acronym
- TOLERANCE
- Status last verified
- Oct 2025
- First submitted
- 26 Oct 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)
- ClinicalTrials.gov ID
- NCT07288021
- Acronym / sponsor ID
- TOLERANCE / 0061-23-BNZ
- Conditions
- Labor, Induced
- Keywords
- induction, balloon catheter, EMLA, Lidocaine/prilocaine, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 17 Dec 2025 (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 goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals.
All participants are 18 or older, carrying a singleton in vertex position and in need of labor induction, are late-preterm or term (34 weeks gestation and onward) and without contraindication to vaginal delivery.
Investigators seek to compare pain levels and patient satisfaction between two groups:
Nulliparous patients, using EMLA or placebo (randomized, double blinded). Multiparous patients, EMLA or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMLA | Experimental | Drug: Topical Analgesia with Lidocaine-Prilocaine cream |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women scheduled for labor induction with balloon catheter.
- 18 years of age or older.
- Singleton pregnancy with a cephalic presentation.
- ≥ 34 completed gestational weeks.
- Does not participate in any other trial that might affect maternal or fetal/neonatal outcomes.
Key exclusion criteria (4 listed)
- Unable or unwilling to provide and sign informed consent forms.
- Known sensitivity to EMLA or placebo substance.
- Known vulvodynia or vaginismus - rendering vaginal examination not possible.
- Any chronic pain syndrome
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 |
|---|---|---|
| Topical Analgesia with Lidocaine-Prilocaine creampatients allocated to \'EMLA\' arm will receive topical analgesia cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made to allow for maximal analgesic affect. | Drug | EMLA |
| Placebopatients allocated to \'Placebo\' arm will receive lubrication with placebo cream prior to speculum insertion, as part of the administration of balloon catheter insertion process. 3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made. | Other | Placebo |
Primary outcome
Pain levels during insertion
Time frame: directly after application and insertion of balloon catheter.
Pain levels during insertion of balloon catheter, as experienced by participant and ranked from 1 to 5 [1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)].
13 secondary outcomes
analgesia while with balloon catheter
Time frame: 6-12 hours
pain score during removal of catheter
Time frame: to be asked directly after removal, on a scale of 1-5.
willingness to undergo cervical ripening with balloon catheter in the future
Time frame: to be asked directly after removal, on a scale of 1-5.
analgesia during delivery
Time frame: From time of balloon insertion until the time of delivery, assessed up to 3 days and to be checked immediately after delivery.
mode of delivery
Time frame: at delivery
neonatal weight
Time frame: immediately after delivery
APGAR [Appearance (color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration (breathing)] score
Time frame: up to 10 minutes after delivery
cord blood gas
Time frame: up to 10 minutes after delivery
Neonatal Intensive Care Unit (NICU) admission
Time frame: from delivery and up to 1 week
neonatal infection
Time frame: 1st week after delivery
duration of insertion procedure
Time frame: balloon insertion duration, estimated as up to 20 minutes
difficulty of insertion
Time frame: to be reported by inserting doctor immediately after insertion procedure is completed, estimated up to 20 minutes.
obstetric trauma
Time frame: up to an hour after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Analgesia with Lidocaine-Prilocaine cream in people with Labor, Induced, run by Bnai Zion Medical Center 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Dec 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dafna Ben Yehuda Raz, MD, resident doctor (+97248359366, dafna.ben-yehuda@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels during insertion (time frame: directly after application and insertion of balloon catheter.). 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 17 Dec 2025.