NCT06953115 Vagal Stimulation Therapy and Preeclampsia
| NCT ID | NCT06953115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Internacional René Mey |
| Condition | Gestational Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2026-10-15 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2026-10-15 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Luz Ma. Adriana Balderas-Peña, Ph.D.
STUDY CHAIR
Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS
Frequently Asked Questions
Who can join the NCT06953115 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06953115 currently recruiting?
Yes, NCT06953115 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fundación Internacional René Mey to inquire about joining.
Where is the NCT06953115 trial being conducted?
This trial is being conducted at Guadalajara, Mexico, Guadalajara, Mexico, Guadalajara, Mexico, Tlajomulco de Zúñiga, Mexico.
Who is sponsoring the NCT06953115 clinical trial?
NCT06953115 is sponsored by Fundación Internacional René Mey. The principal investigator is Luz Ma. Adriana Balderas-Peña, Ph.D. at Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS. The trial plans to enroll 210 participants.