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HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)

RecruitingNAAges 18 Years - anyFemaleInstitut Investigacio Sanitaria Pere Virgili
NCT07528560 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this non-randomized community clinical trial is to test how effective HIFEM (High Intensity Focused Electromagnetic) technology (BTL Emsella) is in strengthening pelvic floor muscles. The study focuses on first-time mothers who have recently given birth (postpartum) via vaginal delivery and are not showing symptoms of dysfunction. The main question this study aims to answer is: \- Can pelvic floor strength be restored after being exposed to weakening risk factors like pregnancy and childbirth? How to study works; The researcher will compare two groups of women to see how their muscles recover: 1. Those who receive the Emsella HIFEM treatment. 2. Those who follow their natural recovery without the treatment. Participant Journey: * Initial Check-up: Once the standard 6-week postpartum recovery period (quarantine) is over. * Eligibility: The researcher checks if participan

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📋 Eligibility rules (as published)
Inclusion Criteria: * Primiparous women * Vaginal delivery. * Single-fetus pregnancy / Singleton pregnancy. * Full-term pregnancy (\> 37 weeks of gestation). * Asymptomatic: No symptoms associated with pelvic floor muscle weakening, such as any type of incontinence or presence of prolapse. * Post-quarantine period: Between 6 and 12 weeks postpartum Exclusion Criteria: * Implanted devices: Such as pacemakers, defibrillators, or neurostimulators. * Electronic implants. * Drug delivery pumps (e.g., insulin pumps or medication infusion pumps). * Metallic implants. * Intrauterine devices (IUDs) containing any type of metal. * Application over the growth plate area. * Severe or life-threatening disorders. * Pulmonary insufficiency. * Cardiac disorders / Heart conditions. * Decompensated hemorrhagic conditions. * Decompensated blood coagulation disorders. * Malignant tumors / Malignancy. * Fever. * Epilepsy. * Menstruation * Pregnant
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What it tests

  • HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA
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Where

1 site
Centro Procrear
Tarragona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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