Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06296134
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-14
Brief Title:
Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation
Sponsor:
Azienda Sanitaria Universitaria Friuli Centrale
Organization:
Azienda Sanitaria Universitaria Friuli Centrale
Study Overview
Official Title:
Does Perineal Massage in Pregnancy Reduce the Levator Ani Muscle Co-activation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CO-LAM23
Brief Summary:
The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle LAM co-activation This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome Participants who co-activate will be enrolled and randomized in 2 groups group A where women themselves perform the perineal massage during the third trimester of pregnancy and group B where women undergo the standard care Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation
Detailed Description:
The levator ani muscle has to relax instead of contracting during the pushing efforts in childbirth However some women consciously or unconsciously co-contract or tighten the levator ani muscle This phenomenon is levator ani muscle co-activation Recently it has been shown that co-activation may be associated with unfavorable obstetric outcomes such as prolonged second stages of labor and higher fetal head station in women with co-contraction
Recently a study assessing the correlation between levator ani muscle co-activation and perineal trauma has been published This study found a significantly higher incidence of severe perineal trauma related to childbirth ie third and fourth-degree lacerations and episiotomies in women with levator ani muscle co-activation This group of patients had approximately three times the risk of a vacuum-assisted vaginal delivery and five times the risk of developing a severe vagino-perineal laceration with potential involvement of the anal sphincter Therefore intervening in these patients with targeted measures to correct LAM co-activation in the third trimester of pregnancy might be promising
Study design All women are informed about this study during the first trimester of pregnancy During the anatomical scan at 20-22 gestational weeks women are screened for eligibility criteria including nulliparity single pregnancy fetus in cephalic presentation and fluency in Italian language Women satisfying the inclusion criteria are asked to participate to this RCT If women agree to participate in the study an informed consent will be signed Thereafter a trans-perineal ultrasound will be performed in order to evaluate the presence of levator ani muscle co-activation A medio-sagittal scan is obtained to identify the following landmarks pubic symphysis fetal head rectum and puborectal muscle In this scan the antero-posterior diameter of the anorectal angle APD is measured which is the minimum distance between the postero-inferior border of the pubic symphysis and the anterior border of the puborectal muscle This measurement is taken both at rest and during maternal pushing Valsalva maneuver Patients with co-activation will be identified by an APD during Valsalva that is smaller than the one observed at rest Patients will be enrolled and randomized only in case of LAM co-activation
A 11 randomization will be done using a specific function of Excel preliminarily prepared by our Statistician Women will be randomized in 2 arms arm A is represented by the treatment perineal massage while arm B is represented by the standard care
At about 30 gestational weeks women randomized to arm A will be trained on how technically perform the perineal massage Participants are instructed to do the perineal massage once daily from 34 gestational weeks until delivery for at least 3 weeks continuously By contrast women randomized to arm B are informed on currently available recommendations to take care for pelvic floor in pregnancy These recommendations include advices on healthy diet physical activity and voiding training
At 37-38 gestational weeks all randomized women are scanned again in order to measure the APD at rest and under Valsalva All anthropometric and clinical data are collected and anonymized
Intra-partum part of the study This part of the project involves data collection on labor delivery and neonatal outcomes The labor and delivery care-providers operate blindly with respect to the antepartum ultrasound measurements
The study was powered based on the primary endpoint which is the 40 reduction in LAM co-activation at term after perineal massage therapy It is necessary to randomize 58 subjects 29 women per group
The primary outcome of this trial is to assess whether the intervention perineal massage compared to the standard care is able to significantly reduce the levator ani co-activation Secondary outcomes are the standardization of the perineal massage and the comparison of perineal trauma prevalence between the 2 arms
Recently a study assessing the correlation between levator ani muscle co-activation and perineal trauma has been published This study found a significantly higher incidence of severe perineal trauma related to childbirth ie third and fourth-degree lacerations and episiotomies in women with levator ani muscle co-activation This group of patients had approximately three times the risk of a vacuum-assisted vaginal delivery and five times the risk of developing a severe vagino-perineal laceration with potential involvement of the anal sphincter Therefore intervening in these patients with targeted measures to correct LAM co-activation in the third trimester of pregnancy might be promising
Study design All women are informed about this study during the first trimester of pregnancy During the anatomical scan at 20-22 gestational weeks women are screened for eligibility criteria including nulliparity single pregnancy fetus in cephalic presentation and fluency in Italian language Women satisfying the inclusion criteria are asked to participate to this RCT If women agree to participate in the study an informed consent will be signed Thereafter a trans-perineal ultrasound will be performed in order to evaluate the presence of levator ani muscle co-activation A medio-sagittal scan is obtained to identify the following landmarks pubic symphysis fetal head rectum and puborectal muscle In this scan the antero-posterior diameter of the anorectal angle APD is measured which is the minimum distance between the postero-inferior border of the pubic symphysis and the anterior border of the puborectal muscle This measurement is taken both at rest and during maternal pushing Valsalva maneuver Patients with co-activation will be identified by an APD during Valsalva that is smaller than the one observed at rest Patients will be enrolled and randomized only in case of LAM co-activation
A 11 randomization will be done using a specific function of Excel preliminarily prepared by our Statistician Women will be randomized in 2 arms arm A is represented by the treatment perineal massage while arm B is represented by the standard care
At about 30 gestational weeks women randomized to arm A will be trained on how technically perform the perineal massage Participants are instructed to do the perineal massage once daily from 34 gestational weeks until delivery for at least 3 weeks continuously By contrast women randomized to arm B are informed on currently available recommendations to take care for pelvic floor in pregnancy These recommendations include advices on healthy diet physical activity and voiding training
At 37-38 gestational weeks all randomized women are scanned again in order to measure the APD at rest and under Valsalva All anthropometric and clinical data are collected and anonymized
Intra-partum part of the study This part of the project involves data collection on labor delivery and neonatal outcomes The labor and delivery care-providers operate blindly with respect to the antepartum ultrasound measurements
The study was powered based on the primary endpoint which is the 40 reduction in LAM co-activation at term after perineal massage therapy It is necessary to randomize 58 subjects 29 women per group
The primary outcome of this trial is to assess whether the intervention perineal massage compared to the standard care is able to significantly reduce the levator ani co-activation Secondary outcomes are the standardization of the perineal massage and the comparison of perineal trauma prevalence between the 2 arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None