Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Antenatal Pelvic Floor Preparation Techniques for Childbirth

NCT02582580

Pregnancy

COMPLETED NA

Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration

NCT03108170

Delivery; Injury, Maternal

COMPLETED NA

Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction

NCT00740428

Pelvic Floor Abnormalities

COMPLETED PHASE2/PHASE3

Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain

NCT04660708

ACTIVE_NOT_RECRUITING NA

Effects of Pelvic Exercises on Birth and Incontinence

NCT07268014

Maternal-Fetal Relations Birth, First Incontinence, Urinary +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Floor Disorders Levator Ani Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

perineal massage

participants randomized to this arm are asked to perform themselves the perineal massage once daily from 34 gestational weeks until delivery.

Group Type EXPERIMENTAL

perineal massage

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes