Vagal Stimulation Therapy and Preeclampsia

Sponsor
Fundación Internacional René Mey
Study ID
NCT06953115
Status
Recruiting
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Conditions

  • Gestational Hypertension
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
May 1, 2025
Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vagal Stimulation Physiotherapy with Trigger Point Release (TEV Group).
    Administration of physiotherapy sessions for vagal stimulation with trigger point release, in addition to personalized antihypertensive treatment.
  • Active Comparator: Positional Release Therapy (TLP Group).
    Administration of positional release therapy sessions, in addition to personalized antihypertensive treatment.

Primary Outcome Measure

Changes in participants' blood pressure from baseline (T0), every 2 weeks (T1, T2, T3...), until the end of the evaluation period (TX). [ Time Frame: From baseline until weeks 4 to 5 after obstetric resolution. ]

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