NCT06402604Completed
Stress Reduction in Formerly Preeclamptic Women; Sofa or Sports
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate stress and cardiovascular risk factors in women with preeclampsia in the medical history. The main questions it aims to answer are: * to improve our understanding of the underlying psychological and physical stress factors in relation to the circulatory risk profile in women with a history of preeclampsia * to examine the effects of mindfullness based stress reduction (MBSR) or aerobic exercise training on hair cortisol and symptoms of mental stress. Participants will undergo pre- and post-intervention pre-conceptional standard cardiovascular assessments, head tilt test and give a hair sample. As intervention they will sport or do mindfulness for 3 months.They will be compared with a control group.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 9 May 2023
- Start date
- 1 Apr 2022
- Primary completion date
- 23 Sept 2024
- Lead sponsor
- Radboud University Medical Center
- NCT number
- NCT06402604
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Apr 2022 to the primary completion date, 23 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medication or supplements that might affect the cardiovascular system
- Currently involved in psychological therapy or mindfullness training.
Other illness
- Pre-existent diabetes mellitus, autoimmune disease, HIV positivity or overt cardio-vascular disease.
Other
- (Physical) inabilities to complete 12 weeks of moderate exercise training
- Pregnancy
- Women who intend to become pregnant within 12 weeks after baseline assessment
Who the study is looking for
- Informed consent given
- Age \> or = 18 years
- Good understanding of Dutch language
- Preeclampsia in prior pregnancy, defined as the combination of gestational hypertension (≥140/90 mmHg, measured twice, six hours or more apart), and proteinuria (consistently ≥300mg/24 hours) after 20 weeks of pregnancy in previously normotensive women, according to International Society for the Study of Hypertension in Pregnancy (Brown, 2018).
- Normotensive at the time of baseline measurements
- Perceived Stress Scale score ≥ 16 or State-Trait Anxiety Inventory (STAI) score ≥ 41 or Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Joris J.A. van Esch Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.