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Clinical trialNCT06953115RecruitingInterventional

Vagal Stimulation Therapy and Preeclampsia

SponsorFundación Internacional René MeyEnrollment210Gestational HypertensionPreeclampsia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Carlos A. García-Becerra, M.Sc.

    Fundación Internacional René Mey

    Principal Investigator
  • Juliette Myriam Laure, M.Sc.

    Fundación Internacional René Mey

    Principal Investigator
  • Luz Ma. Adriana Balderas-Peña, Ph.D.

    Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

    Study Chair
  • René Jaques Mey, Dr. h.c.

    Fundación Internacional René Mey

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Mexico
  • Hospital General de Zona 110, Imss

    Guadalajara, Jalisco, Mexico

    Recruiting
  • Hospital General de Zona 46, Imss

    Guadalajara, Jalisco, Mexico

    Not, yet, recruiting
  • Unidad de Investigación Biomédica 02, Umae He Cmno Imss

    Guadalajara, Jalisco, Mexico

    Not, yet, recruiting
  • Hospital General de Zona 180, Imss

    Tlajomulco de Zúñiga, Jalisco, Mexico

    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Apr 2026
Primary completion
1 May 2027
Completion
1 Jun 2027
Last update posted
9 Apr 2026
Registered enrollment
210
Registry id
NCT06953115

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.