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 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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