Vagus nerve stimulation for mild preeclampsia
Vagal Autonomic Stimulation Physiotherapy (With Trigger Point Release) as an Adjunct to Personalized Antihypertensive Management of Gestational Hypertension Syndrome and Preeclampsia
This trial will try vagus‑nerve stimulation physiotherapy (trigger point release and positional release) to help control blood pressure and inflammation in pregnant women with mild preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundación Internacional René Mey Academic / other |
| Locations | 4 sites (Guadalajara, Jalisco and 3 other locations) |
| Trial ID | NCT06953115 on ClinicalTrials.gov |
What this trial studies
This interventional study applies noninvasive vagal stimulation using physiotherapy techniques (trigger point release and positional release) to pregnant women with newly diagnosed mild preeclampsia. Participants are outpatient women over 18 seen at IMSS hospitals in Guadalajara and must not have chronic hypertension or other major comorbidities. The intervention aims to activate the cholinergic anti‑inflammatory pathway via the vagus nerve to improve blood pressure control and placental blood flow. Safety, blood pressure, inflammatory markers, and pregnancy outcomes will be monitored during follow‑up.
Who should consider this trial
Good fit: Pregnant women over 18 with newly diagnosed mild preeclampsia who have not received prior treatment and can attend outpatient visits at the listed IMSS sites in Guadalajara.
Not a fit: Patients with severe preeclampsia, chronic hypertension, organ dysfunction, immunological disease, or gestational trophoblastic disease are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could lower maternal blood pressure and inflammation, reducing the risk of severe complications and improving outcomes for mother and baby.
How similar studies have performed: Preclinical models have shown promising blood pressure and inflammation effects from vagal stimulation, and some small clinical uses of vagal techniques exist, but rigorous clinical evidence specifically for preeclampsia is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with chronic hypertension. * Concomitant organ dysfunction. * Immunological diseases. * Patients with severe preeclampsia or chronic conditions concomitant with pregnancy. * Patients with gestational trophoblastic disease requiring uterine evacuation or choriocarcinoma associated with hypertension.
Where this trial is running
Guadalajara, Jalisco and 3 other locations
- Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS — Guadalajara, Jalisco, Mexico (Not_yet_recruiting)
- Hospital General de Zona 110, IMSS — Guadalajara, Jalisco, Mexico (Recruiting)
- Hospital General de Zona 46, IMSS — Guadalajara, Jalisco, Mexico (Not_yet_recruiting)
- Hospital General de Zona 180, IMSS — Tlajomulco de Zúñiga, Jalisco, Mexico (Not_yet_recruiting)
Study contacts
- Principal investigator: René Jaques Mey, Dr. h.c. — Fundación Internacional René Mey
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.