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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
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.
Bnai Zion Medical Center
Haifa, Israel
RECRUITINGPain 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
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