[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589338":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":25,"locations":42,"responsibleParty":99,"collaborators":102,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":25,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":25,"enrollmentInfo":115,"targetDuration":25,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Fundación Internacional René Mey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vagal Stimulation Physiotherapy with Trigger Point Release (TEV Group).","EXPERIMENTAL","Administration of physiotherapy sessions for vagal stimulation with trigger point release, in addition to personalized antihypertensive treatment.",[13],"Other: Vagal stimulation physiotherapy with trigger point release",{"label":15,"type":16,"description":17,"interventionNames":18},"Positional Release Therapy (TLP Group).","ACTIVE_COMPARATOR","Administration of positional release therapy sessions, in addition to personalized antihypertensive treatment.",[19],"Other: Positional Release Therapy",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Vagal stimulation physiotherapy with trigger point release","The patient will be instructed to remain in a seated position, with the knee slightly ahead of the feet and the feet firmly planted on the floor, with the hips higher than the knees. The therapist will stand behind the patient. Myofascial release will be performed on the upper trapezius (UT) while the patient slowly turns their head from side to side and lets it drop forward. The therapist will then apply pressure on the opposite side of the rotation.\n\n* Therapist's position: Behind the patient.\n* Patient's position: Seated with the spine in a neutral position.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Positional Release Therapy","A 30-minute session of positional release therapy will be provided every two weeks, in addition to personalized antihypertensive treatment, from the start of treatment (T0) until the final measurement (days 28 to 35 after obstetric resolution).\n\nKeeping the cervical spine in a neutral position, the participant will be asked to lie down in a relaxed supine position. The therapist will progressively apply more pressure to the trigger points identified with their thumb. In the next step, the therapist will move to a more comfortable position that exerts less stress. The therapist will passively hold the patient's upper limbs in an abducted position, with a rest period between each repetition.\n\n* Therapist's position: On the side of the patient.\n* Patient's position: Supine.",[15],[31,35,38,40],{"name":32,"affiliation":33,"role":34},"Luz Ma. Adriana Balderas-Peña, Ph.D.","Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS","STUDY_CHAIR",{"name":36,"affiliation":5,"role":37},"René Jaques Mey, Dr. h.c.","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Juliette Myriam Laure, M.Sc.",{"name":41,"affiliation":5,"role":37},"Carlos A. García-Becerra, M.Sc.",[43,62,74,85],{"facility":33,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"NOT_YET_RECRUITING","Guadalajara","Jalisco","44329","Mexico","MX",{"type":51,"coordinates":52},"Point",[53,54],-103.34749,20.67738,{"lat":54,"lon":53},[57],{"name":58,"role":59,"phone":60,"phoneExt":25,"email":61},"Luz Ma. Adriana Balderas Peña, Ph.D.","CONTACT","33 3668 3000","luz.balderasp@imss.gob.mx",{"facility":63,"status":64,"city":45,"state":46,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Hospital General de Zona 110, IMSS","RECRUITING","44716",{"type":51,"coordinates":67},[53,54],{"lat":54,"lon":53},[70],{"name":71,"role":59,"phone":72,"phoneExt":25,"email":73},"Javier Torres García, M.D.","33 3345 5800","javier.torresgar@imss.gob.mx",{"facility":75,"status":44,"city":45,"state":46,"zip":76,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Hospital General de Zona 46, IMSS","44910",{"type":51,"coordinates":78},[53,54],{"lat":54,"lon":53},[81],{"name":82,"role":59,"phone":83,"phoneExt":25,"email":84},"Leticia Regueira Rodríguez, M.D.","33 3810 0010","dra.regueira@gmail.com",{"facility":86,"status":44,"city":87,"state":46,"zip":88,"country":48,"countryCode":49,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hospital General de Zona 180, IMSS","Tlajomulco de Zúñiga","45653",{"type":51,"coordinates":90},[91,92],-103.44654,20.47421,{"lat":92,"lon":91},[95],{"name":96,"role":59,"phone":97,"phoneExt":25,"email":98},"Dulce Barbosa Alatorre, M.D.","33 3478 2100","dibamx8@yahoo.com.mx",{"type":37,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Carlos Alberto Garcia Becerra, MD, MSc","Principal Investigator, Fundación Internacional René Mey",[103],{"name":104,"class":105},"Coordinación de Investigación en Salud, Mexico","OTHER_GOV","100589338","vagal-stimulation-therapy-and-preeclampsia-100589338",false,"NCT06953115","Vagal Stimulation Therapy and Preeclampsia","Vagal Autonomic Stimulation Physiotherapy (With Trigger Point Release) as an Adjunct to Personalized Antihypertensive Management of Gestational Hypertension Syndrome and Preeclampsia","Inclusion Criteria:\n\n* Outpatient female patients over 18 years old, attending their first appointment and seen in the obstetrics outpatient clinic at the Regional General Hospitals of IMSS Jalisco, with a pregnancy complicated by confirmed mild preeclampsia.\n* No prior treatment.\n* Willing to participate by signing an informed consent form.\n\nExclusion Criteria:\n\n* Patients with chronic hypertension.\n* Concomitant organ dysfunction.\n* Immunological diseases.\n* Patients with severe preeclampsia or chronic conditions concomitant with pregnancy.\n* Patients with gestational trophoblastic disease requiring uterine evacuation or choriocarcinoma associated with hypertension.","FEMALE","18 Years",{"count":116,"type":117},210,"ESTIMATED","INTERVENTIONAL",[120],"NA","Preeclampsia is one of the most common and serious complications of pregnancy, affecting both the mother and baby. It is a condition characterized by high blood pressure and can lead to severe complications, including neurological issues and reduced blood flow to the placenta. Preeclampsia is responsible for a significant number of maternal and perinatal deaths worldwide, with an estimated 14% of maternal mortality in Mexico linked to this condition.\n\nRecent research suggests that disruptions in the body's autonomic nervous system, specifically the balance between the sympathetic and parasympathetic systems, play a role in the development of preeclampsia. The vagus nerve, which is part of the parasympathetic system, has been shown to regulate inflammation and blood pressure. Stimulating this nerve through pharmacological, magnetic, electrical, or physical therapy techniques has shown promise in preclinical models for improving blood pressure control and reducing complications associated with preeclampsia.\n\nTrigger point release therapy modulates the nervous system by reducing sympathetic activity, promoting blood vessel relaxation, lowering heart rate, and enhancing circulation. When combined with standard antihypertensive treatment, this approach may offer additional benefits for blood pressure regulation.\n\nThis study aims to evaluate the effects of vagal autonomic stimulation physiotherapy using trigger point release therapy as a complementary treatment for pregnant women with preeclampsia. Participants will be randomly assigned to receive either standard antihypertensive treatment with positional release therapy (control group) or the same treatment combined with vagal stimulation physiotherapy (intervention group). Researchers will assess the intervention's effectiveness in controlling blood pressure and improving overall maternal and fetal health outcomes.\n\nBy investigating this non-invasive, drug-free approach, this study aims to offer new strategies for managing preeclampsia, potentially improving maternal and fetal health while reducing reliance on medication.",[123,124],"Gestational Hypertension","Preeclampsia",[126,123,127,124,128,129],"Hypertension, Pregnancy-Induced","Pre-Eclampsia","Physical Therapy Techniques","Modalities, Physical Therapy","2026-04-08",{"date":132,"type":133},"2026-04-09","ACTUAL",{"date":135,"type":117},"2026-04-15",{"date":137,"type":117},"2027-06-01",{"name":5,"class":6},4]