Stress Reduction in Formerly Preeclamptic Women; Sofa or Sports (NCT06402604) | Clinical Trial Compass
CompletedNot Applicable
Stress Reduction in Formerly Preeclamptic Women; Sofa or Sports
Netherlands60 participantsStarted 2022-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Pre-existent diabetes mellitus, autoimmune disease, HIV positivity or overt cardio-vascular disease.
* Use of medication or supplements that might affect the cardiovascular system
* (Physical) inabilities to complete 12 weeks of moderate exercise training
* Currently involved in psychological therapy or mindfullness training.
* Pregnancy
* Women who intend to become pregnant within 12 weeks after baseline assessment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perceived stress
Timeframe: Pre-post intervention and 3 months follow up.
2
Anxiety symptoms
Timeframe: Pre-post intervention and 3 months follow up.
3
Depression symptoms
Timeframe: Pre-post intervention and 3 months follow up.