A Phase 4 interventional study of Topical Analgesia with Lidocaine-Prilocaine cream and Placebo in Labor, Induced, sponsored by Bnai Zion Medical Center. Recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Bnai Zion Medical Center · Phase 4, Interventional, and Treatment
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 200 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Bnai Zion Medical Center is the lead sponsor of 104 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Topical Analgesia with Lidocaine-Prilocaine cream
Other: Placebo
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.
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.
Pain levels during insertion
Pain levels during insertion of balloon catheter, as experienced by participant and ranked from 1 to 5 \[1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)\].
Time frame: directly after application and insertion of balloon catheter.
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).
Time frame: 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 \[1 - no pain at all 2 - mild discomfort 3 -strong pain yet bearable 4 -severe pain 5 - unbearable pain (requires cessation of insertion)\].
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
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).
Time frame: 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.
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
mode of delivery - vaginal, operative vaginal of cesarean delivery
Time frame: at delivery
neonatal weight
neonatal weight in grams and percentile according to birth weight curves
Time frame: 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.
Time frame: 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.
Time frame: up to 10 minutes after delivery
Neonatal Intensive Care Unit (NICU) admission
NICU admission of newborn within first week of life
Time frame: from delivery and up to 1 week
neonatal infection
neonatal infection or suspicion of during birth hospitalization
Time frame: 1st week after delivery
duration of insertion procedure
duration of insertion of catheter procedure
Time frame: balloon insertion duration, estimated as up to 20 minutes
difficulty of insertion
difficulty of insertion of catheter, as described by inserting physician
Time frame: 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
Time frame: up to an hour after delivery
Participant Satisfaction After Balloon Catheter Insertion
satisfaction of participant from insertion of balloon catheter, as ranked by participant on a scale of 1-5 (1 - completely unhappy; 2 - slightly unhappy; 3 - ambivalent; 4 - mildly pleased; 5 - very pleased).
Time frame: the patient is to be asked by inserting physician directly after insertion, on a scale of 1-5.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Feb 2026, 24 months after the start.
Of 280 non-industry phase 4 interventional studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 24 months is above that.
Counting every sponsor, half of 295 studies reached it within 18 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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