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NCT06953115Recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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. Recent 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. Trigger 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. This 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. By 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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
210 (estimated)
First submitted
3 Apr 2025
Start date
15 Oct 2026
Primary completion date
1 May 2027
Lead sponsor
Fundación Internacional René Mey
NCT number
NCT06953115

What you commit to

  • Study type: Interventional
  • Planned participants: 210
  • From 15 Oct 2026 to the primary completion date, 1 May 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant organ dysfunction.
  • Patients with severe preeclampsia or chronic conditions concomitant with pregnancy.

Other illness

  • Patients with chronic hypertension.
  • Immunological diseases.
  • Patients with gestational trophoblastic disease requiring uterine evacuation or choriocarcinoma associated with hypertension.

Who the study is looking for

  • 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.
  • No prior treatment.
  • Willing to participate by signing an informed consent form.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital General de Zona 46, IMSS
Coordinator of this site? Confirm its status
GuadalajaraMexicoNot yet recruiting
Hospital General de Zona 110, IMSS
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting
Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS
Coordinator of this site? Confirm its status
GuadalajaraMexicoNot yet recruiting
Hospital General de Zona 180, IMSS
Coordinator of this site? Confirm its status
Tlajomulco de ZúñigaMexicoNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.