Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06953115

Vagal Stimulation Therapy and Preeclampsia

Led by Fundación Internacional René Mey · Updated on 2026-04-09

210

Participants Needed

4

Research Sites

58 weeks

Total Duration

On this page

Sponsors

F

Fundación Internacional René Mey

Lead Sponsor

C

Coordinación de Investigación en Salud, Mexico

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Vagal Stimulation Therapy and Preeclampsia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients over 18 years old
  • Outpatient pregnant women attending their first obstetrics consultation at IMSS Jalisco
  • Confirmed diagnosis of mild preeclampsia
  • No prior antihypertensive treatment
  • Willingness to participate by signing informed consent
Not Eligible

You will not qualify if you...

  • Chronic hypertension
  • Concomitant organ dysfunction
  • Immunological diseases
  • Severe preeclampsia or chronic conditions complicating pregnancy
  • Gestational trophoblastic disease requiring uterine evacuation or choriocarcinoma

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

Guadalajara, Jalisco, Mexico, 44329

Not Yet Recruiting

2

Hospital General de Zona 110, IMSS

Guadalajara, Jalisco, Mexico, 44716

Actively Recruiting

3

Hospital General de Zona 46, IMSS

Guadalajara, Jalisco, Mexico, 44910

Not Yet Recruiting

4

Hospital General de Zona 180, IMSS

Tlajomulco de Zúñiga, Jalisco, Mexico, 45653

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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