NCT06296134 Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation
| NCT ID | NCT06296134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Sanitaria Universitaria Friuli Centrale |
| Condition | Pelvic Floor Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2024-08-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06296134 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Pelvic Floor Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06296134 currently recruiting?
Yes, NCT06296134 is actively recruiting participants. Contact the research team at serena.xodo@gmail.com for enrollment information.
Where is the NCT06296134 trial being conducted?
This trial is being conducted at Udine, Italy.
Who is sponsoring the NCT06296134 clinical trial?
NCT06296134 is sponsored by Azienda Sanitaria Universitaria Friuli Centrale. The trial plans to enroll 58 participants.