Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMLA | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Analgesia with Lidocaine-Prilocaine cream | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. | directly after application and insertion of balloon catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6-12 hours |
| pain score during removal of catheter |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | the patient is to be asked by inserting physician directly after insertion, on a scale of 1-5. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dafna Ben Yehuda Raz, MD, resident doctor | Contact | +97248359366 | dafna.ben-yehuda@b-zion.org.il | |
| Inna Bleicher, MD, MFM specialist | Contact | +97248359366 | inna.bleicher@b-zion.org.il |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Recruiting | Haifa | 3339419 | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Both creams (EMLA and placebo) are specially made in similar containers, labeled as A and B. Head of pharmacy in the study's medical center alone is aware which is EMLA or placebo. Both substances are of similar smell, texture and color.
|
| Placebo | Other | 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 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)]. |
| 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). | 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. | 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 | at delivery |
| neonatal weight | neonatal weight in grams and percentile according to birth weight curves | 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. | 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. | up to 10 minutes after delivery |
| Neonatal Intensive Care Unit (NICU) admission | NICU admission of newborn within first week of life | from delivery and up to 1 week |
| neonatal infection | neonatal infection or suspicion of during birth hospitalization | 1st week after delivery |
| duration of insertion procedure | duration of insertion of catheter procedure | balloon insertion duration, estimated as up to 20 minutes |
| difficulty of insertion | difficulty of insertion of catheter, as described by inserting physician | 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 | up to an hour after delivery |