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NCT Number: NCT06696495

Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinica Rayo, Seville, SEVILLA, Spain

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About this study

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 evaluate their impact on foot function, thus contributing to the prevention and management of podiatric and orthopedic problems in pregnant women.

The general objective of this study is to evaluate the morphofunctional and baropodometric changes of the foot and ankle in pregnant women from the pre-gestational period to the postpartum period. Specific objectives include determining changes in foot and ankle size and width at different stages, assessing foot function using the AOFAS (Ankle and Foot Outcome Score), FPI (Foot Posture Index) and FFI (Foot Function Index) indices, analyzing plantar pressure distribution and baropodometric changes, and correlating morphofunctional and baropodometric changes with weeks of gestation and maternal weight.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • History of previous foot or ankle injuries that may alter measurements.

Treatment and study plan

Measurement of the size and width of the foot

Diagnostic Test

Assessment of the height of the plantar arch using a podoscope, and application of functional scales such as the AOFAS (Ankle and Foot Outcome Score), the FPI (Foot Posture Index) and the FFI (Foot Function Index). In addition, the distribution of plantar pressure and the centre of pressure (COP)

Primary outcomes

  1. Ankle and Foot Outcome Score

    Time frame: 3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy

    Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy. The score is 0 to 100 points.

  2. Foot Fuction Index Score

    Time frame: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy

    Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy. The score is 0 to 100 points.

  3. Measurement of the length and width of the foot

    Time frame: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy

    Completion of the scale before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Evaluation of Morphofunctional and Baropodometric Changes in the Foot and Ankle of Pregnant Women: Longitudinal Study from the Pregestational Stage to the Postpartum Period

Acronym: FOOTpreg

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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