Gestational HypertensionNCT06953115
Vagal Stimulation Therapy and Preeclampsia
A study testing Vagal stimulation physiotherapy with trigger point release and Positional Release Therapy in people with Gestational Hypertension and Preeclampsia, run by Fundación Internacional René Mey at 4 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Hypertension, Preeclampsia
- What is being tested?
- Vagal stimulation physiotherapy with trigger point release and Positional Release Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesMexico
- Study dates
- 15 Oct 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico4 sites, 4 recruiting
- Not yet recruiting
Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS
Guadalajara, Jalisco, 44329
Luz Ma. Adriana Balderas Peña, Ph.D., 33 3668 3000, luz.balderasp@imss.gob.mx
- Recruiting
Hospital General de Zona 110, IMSS
Guadalajara, Jalisco, 44716
Javier Torres García, M.D., 33 3345 5800, javier.torresgar@imss.gob.mx
- Not yet recruiting
Hospital General de Zona 46, IMSS
Guadalajara, Jalisco, 44910
Leticia Regueira Rodríguez, M.D., 33 3810 0010, dra.regueira@gmail.com
- Not yet recruiting
Hospital General de Zona 180, IMSS
Tlajomulco de Zúñiga, Jalisco, 45653
Dulce Barbosa Alatorre, M.D., 33 3478 2100, dibamx8@yahoo.com.mx
About this study
Official title: Vagal Autonomic Stimulation Physiotherapy (With Trigger Point Release) as an Adjunct to Personalized Antihypertensive Management of Gestational Hypertension Syndrome and Preeclampsia
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.
Read more
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.
Read the detailed description
Among hypertensive disorders of pregnancy, preeclampsia is the most common medical complication and is associated with high medical and social costs, making it a significant public health concern.
Although its global prevalence is unknown, preeclampsia is implicated in 14% of maternal deaths worldwide. In Mexico, it accounts for approximately 14% of maternal mortality, corresponding to a rate of 30.4 per 100,000 live births, and 17.2% of total perinatal deaths. Of these maternal deaths, 30% to 70% result from neurological complications where cerebral autoregulation is lost, leading to vasospasm, reduced blood flow, and ischemic and infarcted areas in the placenta.
Recent evidence suggests that dysregulation of the cholinergic anti-inflammatory pathway (CAP) may contribute to preeclampsia development. This pathway connects the central nervous system-via the vagus nerve-to mechanisms regulating inflammation in the body. It is influenced by the downregulation of the α7 nicotinic acetylcholine receptor, which has been associated with systemic inflammation in preeclampsia. Additionally, some electrical, pharmacological, magnetic, and physical vagal stimulation techniques targeting this pathway have shown promising results in preclinical models of preeclampsia, making vagus nerve activation a potential strategy for managing this pregnancy complication. Clinically, various vagal stimulation techniques, such as deep breathing, progressive relaxation, and transcranial magnetic stimulation, have been approved for treating depression and epilepsy in pregnant women.
Primarily linked to the parasympathetic nervous system, the vagus nerve is also influenced by the sympathetic nervous system through peripheral receptors. Trigger point stimulation therapy in physiotherapy can block sympathetic nervous system activity, reducing peripheral vascular resistance, venous return, heart rate, and myocardial contractility by promoting systemic arterial and venous vasodilation. In this context, physiotherapy involving trigger point release could serve as an adjunct treatment for blood pressure control in preeclamptic patients by modulating the peripheral nervous system. However, its impact on autonomic tone has not yet been reported.
This study aims to explore the benefits of vagal stimulation through trigger point release, combined with medical treatment for preeclampsia-an approach that has not been fully investigated in our setting. This protocol presents a non-invasive complementary technique to support personalized pharmacological management of preeclamptic patients. By enhancing the vasorelaxant response derived from autonomic nervous system activity, this intervention may help reduce blood pressure levels and biochemical markers associated with preeclampsia.
Objective: To determine the effect of vagal autonomic stimulation physiotherapy with trigger point release on hemodynamic control compared to positional release therapy as adjuvant treatments in personalized antihypertensive therapy for gestational hypertension syndrome preeclampsia.
Methods: This is an Experimental, randomized, double-blind, parallel-group clinical trial with an open-label intervention administration, with a control group (2:1 ratio), designed to assess the effectiveness of vagal stimulation physiotherapy with trigger point release as an adjuvant treatment for mild preeclampsia in pregnant women. The study will be conducted over 12 months at several hospitals of the Mexican Institute of Social Security.
Participants:
Women over 18, beneficiaries of the Mexican Institute of Social Security (IMSS), diagnosed with mild preeclampsia, will be randomly assigned to one of two groups:
- Intervention group: Receives vagal stimulation physiotherapy with trigger point release every two weeks, along with personalized antihypertensive treatment.
- Control group: Receives positional release therapy every two weeks, along with personalized antihypertensive treatment.
Study Design:
- Blinding: Double-blind (patients and researcher performing statistical analysis).
- Sample Size: 210 patients (147 in the experimental group, 63 in the control group).
- Randomization: Block randomization generated by computer.
Inclusion Criteria: Outpatient pregnant women aged 18 years or older who are attending their first obstetrics consultation at the Regional General Hospitals of IMSS Jalisco with a confirmed diagnosis of mild preeclampsia. Participants must have no prior antihypertensive treatment and must be willing to participate by signing an informed consent form.
Exclusion Criteria: Patients with chronic hypertension, concomitant organ dysfunction, or immunological diseases will be excluded from the study. Additionally, those with severe preeclampsia or any chronic condition complicating pregnancy will not be eligible. Patients diagnosed with gestational trophoblastic disease requiring uterine evacuation or choriocarcinoma will also be excluded.
- Conditions
- Gestational Hypertension, Preeclampsia
- Being tested
- Vagal stimulation physiotherapy with trigger point release, Positional Release Therapy
- Keywords
- Hypertension, Pregnancy-Induced, Gestational Hypertension, Pre-Eclampsia, Preeclampsia, Physical Therapy Techniques, Modalities, Physical Therapy
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal stimulation physiotherapy with trigger point releaseOther
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 TherapyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Positional Release Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
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).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
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).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
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).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
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).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Hematological parameters (Changes in complete blood count with platelet count in the participants)
Changes in complete blood count with platelet count in the participants, measured in cells per cubic millimeter (cel/mm3), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum aspartate aminotransferase levels in the participants)
Changes in serum aspartate aminotransferase levels in the participants, measured in milli-international units per milliliter (mUI/mL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum alanine aminotransferase levels in the participants)
Changes in serum alanine aminotransferase levels in the participants, measured in milli-international units per milliliter (mUI/mL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum lactate dehydrogenase levels in the participants)
Changes in serum lactate dehydrogenase levels in the participants, measured in milli-international units per milliliter (mUI/mL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum gamma-glutamyl transferase levels in the participants)
Changes in serum gamma-glutamyl transferase levels in the participants, measured in milli-international units per milliliter (mUI/mL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum total protein levels in the participants)
Changes in serum total protein levels in the participants, measured in grams per deciliter (g/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum albumin levels in the participants)
Changes in serum albumin levels in the participants, measured in grams per deciliter (g/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum globulin levels in the participants)
Changes in serum globulin levels in the participants, measured in grams per deciliter (g/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum albumin/globulin ratio in the participants)
Changes in serum albumin/globulin ratio in the participants, from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum total cholesterol levels in the participants)
Changes in serum total cholesterol levels in the participants, measured in milligrams per deciliter (mg/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum HDL cholesterol levels in the participants)
Changes in serum HDL cholesterol levels in the participants, measured in milligrams per deciliter (mg/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum LDL cholesterol levels in the participants)
Changes in serum LDL cholesterol levels in the participants, measured in milligrams per deciliter (mg/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum VLDL cholesterol levels in the participants)
Changes in serum VLDL cholesterol levels in the participants, measured in milligrams per deciliter (mg/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum triglyceride levels in the participants)
Changes in serum triglyceride levels in the participants, measured in milligrams per deciliter (mg/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in serum C-reactive protein levels in the participants)
Changes in serum C-reactive protein levels in the participants, measured in milligrams per deciliter (mg/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in serum D-dimer levels in the participants)
Changes in serum D-dimer levels in the participants, measured in micrograms per deciliter (μg/dL), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in prothrombin time in the participants)
Changes in prothrombin time in the participants, measured in seconds (seg), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in activated partial thromboplastin time in the participants)
Changes in activated partial thromboplastin time in the participants, measured in seconds (seg), from baseline (T0) and every 2 weeks thereafter (T1, T2, T3...) until the end of the evaluation period (TX).
Measured: From baseline until 4 to 5 weeks after obstetric resolution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial with an open-label intervention administration
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Internacional René Mey
- Sponsor type
- University, hospital or other
- Collaborators
- Coordinación de Investigación en Salud, Mexico
- Responsible party
- Principal investigator, Carlos Alberto Garcia Becerra, MD, MSc, Fundación Internacional René Mey
- Investigators
- Luz Ma. Adriana Balderas-Peña, Ph.D., Study chair, Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSSRené Jaques Mey, Dr. h.c., Principal investigator, Fundación Internacional René MeyJuliette Myriam Laure, M.Sc., Principal investigator, Fundación Internacional René MeyCarlos A. García-Becerra, M.Sc., Principal investigator, Fundación Internacional René Mey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953115
- Sponsor's protocol ID
- R-2025-785-018
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagal Autonomic Stimulation Physiotherapy (With Trigger Point Release) as an Adjunct to Personalized Antihypertensive Management of Gestational Hypertension Syndrome and Preeclampsia
- ClinicalTrials.gov ID
- NCT06953115
- Acronym / sponsor ID
- R-2025-785-018
- Conditions
- Gestational Hypertension, Preeclampsia
- Keywords
- Hypertension, Pregnancy-Induced, Gestational Hypertension, Pre-Eclampsia, Preeclampsia, Physical Therapy Techniques, Modalities, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fundación Internacional René MeyUniversity, hospital or other
- Collaborators
- Coordinación de Investigación en Salud, Mexico
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Among hypertensive disorders of pregnancy, preeclampsia is the most common medical complication and is associated with high medical and social costs, making it a significant public health concern.
Although its global prevalence is unknown, preeclampsia is implicated in 14% of maternal deaths worldwide. In Mexico, it accounts for approximately 14% of maternal mortality, corresponding to a rate of 30.4 per 100,000 live births, and 17.2% of total perinatal deaths. Of these maternal deaths, 30% to 70% result from neurological complications where cerebral autoregulation is lost, leading to vasospasm, reduced blood flow, and ischemic and infarcted areas in the placenta.
Recent evidence suggests that dysregulation of the cholinergic anti-inflammatory pathway (CAP) may contribute to preeclampsia development. This pathway connects the central nervous system-via the vagus nerve-to mechanisms regulating inflammation in the body. It is influenced by the downregulation of the α7 nicotinic acetylcholine receptor, which has been associated with systemic inflammation in preeclampsia. Additionally, some electrical, pharmacological, magnetic, and physical vagal stimulation techniques targeting this pathway have shown promising results in preclinical models of preeclampsia, making vagus nerve activation a potential strategy for managing this pregnancy complication. Clinically, various vagal stimulation techniques, such as deep breathing, progressive relaxation, and transcranial magnetic stimulation, have been approved for treating depression and epilepsy in pregnant women.
Primarily linked to the parasympathetic nervous system, the vagus nerve is also influenced by the sympathetic nervous system through peripheral receptors. Trigger point stimulation therapy in physiotherapy can block sympathetic nervous system activity, reducing peripheral vascular resistance, venous return, heart rate, and myocardial contractility by promoting systemic arterial and venous vasodilation. In this context, physiotherapy involving trigger point release could serve as an adjunct treatment for blood pressure control in preeclamptic patients by modulating the peripheral nervous system. However, its impact on autonomic tone has not yet been reported.
This study aims to explore the benefits of vagal stimulation through trigger point release, combined with medical treatment for preeclampsia-an approach that has not been fully investigated in our setting. This protocol presents a non-invasive complementary technique to support personalized pharmacological management of preeclamptic patients. By enhancing the vasorelaxant response derived from autonomic nervous system activity, this intervention may help reduce blood pressure levels and biochemical markers associated with preeclampsia.
Objective: To determine the effect of vagal autonomic stimulation physiotherapy with trigger point release on hemodynamic control compared to positional release therapy as adjuvant treatments in personalized antihypertensive therapy for gestational hypertension syndrome preeclampsia.
Methods: This is an Experimental, randomized, double-blind, parallel-group clinical trial with an open-label intervention administration, with a control group (2:1 ratio), designed to assess the effectiveness of vagal stimulation physiotherapy with trigger point release as an adjuvant treatment for mild preeclampsia in pregnant women. The study will be conducted over 12 months at several hospitals of the Mexican Institute of Social Security.
Participants:
Women over 18, beneficiaries of the Mexican Institute of Social Security (IMSS), diagnosed with mild preeclampsia, will be randomly assigned to one of two groups:
- Intervention group: Receives vagal stimulation physiotherapy with trigger point release every two weeks, along with personalized antihypertensive treatment.
- Control group: Receives positional release therapy every two weeks, along with personalized antihypertensive treatment.
Study Design:
- Blinding: Double-blind (patients and researcher performing statistical analysis).
- Sample Size: 210 patients (147 in the experimental group, 63 in the control group).
- Randomization: Block randomization generated by computer.
Inclusion Criteria: Outpatient pregnant women aged 18 years or older who are attending their first obstetrics consultation at the Regional General Hospitals of IMSS Jalisco with a confirmed diagnosis of mild preeclampsia. Participants must have no prior antihypertensive treatment and must be willing to participate by signing an informed consent form.
Exclusion Criteria: Patients with chronic hypertension, concomitant organ dysfunction, or immunological diseases will be excluded from the study. Additionally, those with severe preeclampsia or any chronic condition complicating pregnancy will not be eligible. Patients diagnosed with gestational trophoblastic disease requiring uterine evacuation or choriocarcinoma will also be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial with an open-label intervention administration
| Arm | Type | Receives |
|---|---|---|
| Vagal Stimulation Physiotherapy with Trigger Point Release (TEV Group). | Experimental | Other: Vagal stimulation physiotherapy with trigger point releaseAdministration of physiotherapy sessions for vagal stimulation with trigger point release, in addition to personalized antihypertensive treatment. |
| Positional Release Therapy (TLP Group). | Active comparator | Other: Positional Release TherapyAdministration of positional release therapy sessions, in addition to personalized antihypertensive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagal stimulation physiotherapy with trigger point releaseThe 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. | Other | Vagal Stimulation Physiotherapy with Trigger Point Release (TEV Group). |
| Positional Release TherapyA 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. | Other | Positional Release Therapy (TLP Group). |
Primary outcome
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.
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).
Changes in participants' heart rate 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.
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).
22 secondary outcomes
Biochemical parameters of renal function (Changes in serum creatinine levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of renal function (Changes in serum Urea levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of renal function (Changes in serum uric acid levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of renal function (Changes in Glomerular filtration rate in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Hematological parameters (Changes in complete blood count with platelet count in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum aspartate aminotransferase levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum alanine aminotransferase levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum lactate dehydrogenase levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum gamma-glutamyl transferase levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum total protein levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum albumin levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum globulin levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum albumin/globulin ratio in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum total cholesterol levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum HDL cholesterol levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum LDL cholesterol levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum VLDL cholesterol levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical parameters of hepatic function (Changes in serum triglyceride levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in serum C-reactive protein levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in serum D-dimer levels in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in prothrombin time in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Biochemical Parameters of Inflammatory and Endothelial Dysfunction Response (Changes in activated partial thromboplastin time in the participants)
Time frame: From baseline until 4 to 5 weeks after obstetric resolution.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gestational Hypertension
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingPhase 2
Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy
Hypertension
Enrolling by invitation
MumCare: Mum's Cardiovascular Health for Life
Hypertensive Disorder of Pregnancy, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS
Guadalajara, Mexico
Luz Ma. Adriana Balderas-Peña, Ph.D. study chair
Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS
René Jaques Mey, Dr. h.c. principal investigator
Fundación Internacional René Mey
Juliette Myriam Laure, M.Sc. principal investigator
Fundación Internacional René Mey
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal stimulation physiotherapy with trigger point release and Positional Release Therapy in people with Gestational Hypertension and Preeclampsia, run by Fundación Internacional René Mey at 4 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.