Clinical trial NCT06696495: Evaluation of Morphofunctional and Baropodometric Changes in Pregnant Women
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy Related
Foot Diseases
Keywords: pregnancy
foot diseases
Postural Balance
Foot Morphology
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of healthy women between 20 and 35 years of age who meet the established inclusion criteria. If the participants are pregnant, they must be in the first trimester of pregnancy, that is, before week 12. It will be ensured that they do not have chronic or acute pathologies, such as arthritis or vascular or metabolic problems, that could interfere with the analysis of the biomechanical variables. In addition, the participants must not have had previous surgeries on the foot or ankle. On the other hand, women with multiple pregnancies will be excluded from the study, as well as those who suffer from conditions that affect the gait or the structure of the foot, and those who have a history of previous injuries to the foot or ankle that could alter the measurements.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy women between 20 and 35 years old.
2. If pregnant, they must be in the first trimester of pregnancy (before week 12).
3. Absence of chronic or acute pathologies that may interfere with the analysis of biomechanical variables (arthritis, vascular or metabolic problems).
4. Not having had previous foot or ankle surgeries.

Exclusion Criteria:

1. Women with multiple pregnancies (twin or multiple pregnancies increase biomechanical variations).
2. Conditions that affect gait or foot structure (arthritis, neuropathies, or other orthopedic problems).
3. History of previous foot or ankle injuries that may alter measurements.

Primary outcomes:
measure: Ankle and Foot Outcome Score
timeFrame: 3 times. before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
measure: Foot Fuction Index Score
timeFrame: 3 times. Before pregnancy, at 4 months of pregnancy and at 3 months post-pregnancy
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Clinica Rayo
city: Sevilla
country: Spain
facility: Universidad de Sevilla
Study officials:
References: