Vagal Stimulation Therapy and Preeclampsia

NCT06953115 | Recruiting DMC

• 1 other identifier: R-2025-785-018
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

Brief Summary

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

Preeclampsia; Gestational Hypertension

Keywords

Hypertension, Pregnancy-Induced; Gestational Hypertension; Pre-Eclampsia; Preeclampsia; Physical Therapy Techniques; Modalities, Physical Therapy

Outcome Measures

Primary Outcomes (2)

• Changes in participants' blood pressure from baseline (T0), every 2 weeks (T1, T2, T3...), until the end of the evaluation period (TX).

  Observed changes in the measurement of participants' diastolic and systolic blood pressure, recorded at baseline (T0), every 2 weeks (T1, T2, T3...), until the end of the evaluation period (TX).

  From baseline until weeks 4 to 5 after obstetric resolution.

• Changes in participants' heart rate from baseline (T0), every 2 weeks (T1, T2, T3...), until the end of the evaluation period (TX).

  Observed changes in the measurement of participants' heart rate, recorded at baseline (T0), every 2 weeks (T1, T2, T3...), until the end of the evaluation period (TX).

  From baseline until weeks 4 to 5 after obstetric resolution.

Secondary Outcomes (22)

• Biochemical parameters of renal function (Changes in serum creatinine levels in the participants)

  From baseline until 4 to 5 weeks after obstetric resolution.

• Biochemical parameters of renal function (Changes in serum Urea levels in the participants)

  From baseline until 4 to 5 weeks after obstetric resolution.

• Biochemical parameters of renal function (Changes in serum uric acid levels in the participants)

  From baseline until 4 to 5 weeks after obstetric resolution.

• Biochemical parameters of renal function (Changes in Glomerular filtration rate in the participants)

  From baseline until 4 to 5 weeks after obstetric resolution.

• Hematological parameters (Changes in complete blood count with platelet count in the participants)

  From baseline until 4 to 5 weeks after obstetric resolution.

Study Arms (2)

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.

Other: Vagal stimulation physiotherapy with trigger point release

Positional Release Therapy (TLP Group).

ACTIVE COMPARATOR

Administration of positional release therapy sessions, in addition to personalized antihypertensive treatment.

Other: Positional Release Therapy

Interventions

Positional Release Therapy OTHER

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). Keeping 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. * Therapist's position: On the side of the patient. * Patient's position: Supine.

Positional Release Therapy (TLP Group).

Vagal stimulation physiotherapy with trigger point release OTHER

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. * Therapist's position: Behind the patient. * Patient's position: Seated with the spine in a neutral position.

Vagal Stimulation Physiotherapy with Trigger Point Release (TEV Group).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Internacional René Mey: lead
• Coordinación de Investigación en Salud, Mexico: collaborator

Study Sites (4)

Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

Guadalajara, Jalisco, 44329, Mexico

NOT YET RECRUITING

Hospital General de Zona 110, IMSS

Guadalajara, Jalisco, 44716, Mexico

RECRUITING

Hospital General de Zona 46, IMSS

Guadalajara, Jalisco, 44910, Mexico

NOT YET RECRUITING

Hospital General de Zona 180, IMSS

Tlajomulco de Zúñiga, Jalisco, 45653, Mexico

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

• Juliette Myriam Laure, M.Sc.

  Fundación Internacional René Mey

  PRINCIPAL INVESTIGATOR

• Carlos A. García-Becerra, M.Sc.

  Fundación Internacional René Mey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is designed as a double-blind, non-pharmacological clinical trial with a pre-test/post-test design. Both the participants and the outcome evaluator conducting the statistical analysis will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Fundación Internacional René Mey

Model Details: Clinical trial with an open-label intervention administration

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: May 1, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

ME (4)