Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT06296134

Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation

Led by Azienda Sanitaria Universitaria Friuli Centrale · Updated on 2024-08-02

58

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women who are nulliparous
  • Pregnant with a single fetus
  • Fetus in cephalic (head-down) position
  • Fluent in Italian language
  • Age between 18 and 40 years
Not Eligible

You will not qualify if you...

  • Multiparous women
  • Age younger than 18 years or older than 40 years
  • History of urinary or fecal incontinence
  • Contraindications to vaginal delivery (e.g., placenta previa, vasa previa)
  • Twin or multiple pregnancy
  • Language barrier
  • Body mass index (BMI) of 30 or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Serena Xodo

Udine, Italy, 33100

Actively Recruiting

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Research Team

S

Serena Xodo, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation | DecenTrialz