Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women (NCT06696495) | Clinical Trial Compass
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Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women
Spain100 participantsStarted 2025-01
Plain-language summary
Pregnancy causes physiological and biomechanical changes in the female body, such as weight gain and hormonal changes, which can affect the structure and function of the foot and ankle. These adaptations can influence gait, balance and stability. However, the temporal evolution of these changes in the foot and ankle before, during and after pregnancy is not well documented. This study aims to characterize and quantify these changes, as well as their impact on foot function, with the aim of contributing to the prevention and management of podiatric and orthopedic problems in pregnant women.
Who can participate
Age range
20 Years – 35 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
. Healthy women between 20 and 35 years old.
. If pregnant, they must be in the first trimester of pregnancy (before week 12).
. Absence of chronic or acute pathologies that may interfere with the analysis of biomechanical variables (arthritis, vascular or metabolic problems).
. Not having had previous foot or ankle surgeries.
Exclusion criteria
. Women with multiple pregnancies (twin or multiple pregnancies increase biomechanical variations).
. Conditions that affect gait or foot structure (arthritis, neuropathies, or other orthopedic problems).
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
Ankle and Foot Outcome Score
Timeframe: 3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
2
Foot Fuction Index Score
Timeframe: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
3
Measurement of the length and width of the foot
Timeframe: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy