Vagal Stimulation Therapy and Preeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundación Internacional René Mey
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with chronic hypertension.
Concomitant organ dysfunction.
Immunological diseases.
Patients with severe preeclampsia or chronic conditions concomitant with pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Vagal stimulation physiotherapy with trigger point release
Other interventionThe 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 interventionA 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.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Vagal Stimulation Physiotherapy with Trigger Point Release (TEV Group).Experimental treatment 1 intervention
Group B: Positional Release Therapy (TLP Group).Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
From baseline until weeks 4 to 5 after obstetric resolution.2
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).
Time frame
From baseline until weeks 4 to 5 after obstetric resolution.Secondary outcomes
1
Biochemical parameters of renal function (Changes in serum creatinine levels in the participants)
Changes in serum creatinine levels in the participants, measured in milligrams per milliliter (mg/mL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Time frame
From baseline until 4 to 5 weeks after obstetric resolution.2
Biochemical parameters of renal function (Changes in serum Urea levels in the participants)
Changes in serum Urea levels in the participants, measured in milligrams per milliliter (mg/mL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Time frame
From baseline until 4 to 5 weeks after obstetric resolution.3
Biochemical parameters of renal function (Changes in serum uric acid levels in the participants)
Changes in serum uric acid levels in the participants, measured in milligrams per milliliter (mg/mL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Time frame
From baseline until 4 to 5 weeks after obstetric resolution.4
Biochemical parameters of renal function (Changes in Glomerular filtration rate in the participants)
Changes in Glomerular filtration rate in the participants, measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Time frame
From baseline until 4 to 5 weeks after obstetric resolution.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundación Internacional René Mey
Lead sponsor
Coordinación de Investigación en Salud, Mexico
Collaborator
Source ClinicalTrials.gov