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NCT Number: NCT05733377

Non-invasive Imaging Technique for the Study of Lordosis in Pregnant Women and Its Relationship to Birth Outcome

The study consists of collecting measurement data of the rachis in pregnant women and the subsequent outcome of her delivery.

This will make it possible to validate a non-invasive imaging technique through software that can be used to study this anatomical curve proposing a new measurement method for the angle of lordosis.

Finally, with the research data, the investigators will try to find a correlation between these variables (angle of lordosis and delivery outcome.

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Key information

Conditions

Pregnancy Outcome Back Disorder Biomechanics Biomedical Technology Diagnostic Imaging

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Alcalá

Alcalá de Henares, Madrid, 28871, Spain

Location status: Recruiting

Location contact

Susana N Núñez Nagy, PhD

CONTACT

[email protected]

0034918852524

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • pregnant women between 20 and 40 years old with a low-risk pregnancy

Exclusion criteria

  • Pregnant women under 20 years and over 40 years of age or with a significant lumbar pathology or with a very high-risk pregnancy or with IMC >35

Treatment and study plan

Arrow Test

Diagnostic Test

It consists of taking the widest measurement between the rope of a plumb bob on her upper and lower back.

Angle measurement by imaging device

Diagnostic Test

First, three anatomical landmarks are located, and a sticker is placed on each of them: the 12th thoracic vertebra at its intersection with the midline descending from the axilla, the greater trochanter, and the anterior superior iliac spine. After this, the woman will be asked to stand in a normal position facing forward with her hands crossed over her shoulders, and a picture will be taken and pixelated with anything that could identify her. The angle formed by the three stickers will be measured with this image and the software.

Primary outcomes

  1. Lordosis angle using an app

    Time frame: 2025

    Differentiation between lordosis, hyperlordosis and lumbar rectification

Secondary outcomes

  1. Lordosis angle by means of arrow test

    Time frame: 2025

    Differentiation between lordosis, hyperlordosis and lumbar rectification.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Collaborators

  • Hospital Universitario de Fuenlabrada

Registry information

Official study title

Validation of a Non-invasive Image Technique for Studying Pregnant Women´s Lordosis. Relation Between Lordosis and Childbirth Outcome.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2023
Registry last updated
Nov 8, 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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