Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation (CO-LAM23)

August 1, 2024 updated by: Azienda Sanitaria Universitaria Friuli Centrale

Does Perineal Massage in Pregnancy Reduce the Levator Ani Muscle Co-activation?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (i.e., 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 1:1 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 Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: pregnant women with the following characteristics:

  • nulliparous
  • single pregnancy
  • cephalic presentation of the fetus
  • Italian language fluency

Exclusion Criteria:

  • multiparous
  • age < 18 y, age > 40 y
  • previous urinary or fecal incontinence
  • contraindications to vaginal delivery (such as placenta previa, vasa previa, etc)
  • twin pregnancy
  • language barrier
  • BMI at or > 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: perineal massage
participants randomized to this arm are asked to perform themselves the perineal massage once daily from 34 gestational weeks until delivery.
Behavioral: perineal massage
women affected by LAM co-activation allocated to the intervention "perineal massage" are asked to perform the perineal massage once daily from 34 gestational weeks until delivery. Women are trained to correctly perform the perineal massage at 30 gestaitonal weeks.
No Intervention: standard care
participants randomized to this arm are asked to care for their pelvic floor according to the standard practice, which includes healthy diet, weight gain control, physical activity and voiding training therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the percentages of women without levator ani muscle co-activation after treatment or after standard care, evaluated at 37-38 weeks of gestation, using chi square test.
Time Frame: at 20 gestational weeks and at 37-40 gestational weeks

All women who consent to participate in the study will be scanned through a trans-perineal ultrasound at 20 weeks. Co-activation is defined when the levator ani muscle antero-posterior diameter under Valsalva manueuver is lower than the same diameter measured at rest, with trans-perineal ultrasound.

In case of LAM co-activation women will be recruited and randomized into two groups: the perineal massage group vs the standard care group. All randomized women will be evaluated with trans-perineal ultrasound for the levator ani muscle antero-posterior diameter measurement at 37-38 gestational weeks.

To evaluate the effectiveness of the perineal massage, the percentages of women without LAM co-activation after treatment or after standard care, evaluated at 37-38 weeks, will be compared. For the comparison a chi square test will be used.
at 20 gestational weeks and at 37-40 gestational weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups
Time Frame: immediately after fetus delivery

The comparisons between groups will occur through chi-square tests for categorical variables and Student's t-tests for continuous variables.

Vaginal tears are classified into first- degree, second- degree vaginal laceration, obstetric anal sphincter injury (OASI) and episiotomy
immediately after fetus delivery
percentage of women who completely adhere to perineal massage, i.e. who perform the perineal massage once a day, at least 5 days a week, from 34 gestational weeks until delivery.
Time Frame: from 34 gestational weeks until the moment of delivery (between 37 weeks and 41 weeks and 3 days of gestation).
for the effectiveness of perineal massage, participants in the "perineal massage" arm should perform the massage once a day, at least 5 days a week, from 34 gestational weeks until delivery. Participants will be asked to complete a diary, noting the days on which they perform the perineal massage.
from 34 gestational weeks until the moment of delivery (between 37 weeks and 41 weeks and 3 days of gestation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria Universitaria Friuli Centrale

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17501 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

immediately after publication

IPD Sharing Access Criteria

to gain access data requestors should contact the principal investigator: Serena Xodo, e-mail: serena.xodo@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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