Vagal Stimulation Therapy and Preeclampsia
Recruiting · NCT06953115 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundación Internacional René Mey
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
4 locations listed.
- Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS - Guadalajara, Jalisco, Mexico
- Hospital General de Zona 110, IMSS - Guadalajara, Jalisco, Mexico
- Hospital General de Zona 46, IMSS - Guadalajara, Jalisco, Mexico
- Hospital General de Zona 180, IMSS - Tlajomulco de Zúñiga, Jalisco, Mexico