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Recruiting NCT05733377

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

Observational Pregnancy Outcome Biomechanics Back Disorder Diagnostic Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arrow Test, Angle measurement by imaging device.
Who it may be relevant to
Registry conditions: Pregnancy Outcome, Biomechanics, Back Disorder, Diagnostic Imaging. Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test Arrow Test
    It consists of taking the widest measurement between the rope of a plumb bob on her upper and lower back.
  • Diagnostic test Angle measurement by imaging device
    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 measu

Primary outcome measures

  • Lordosis angle using an app [Time frame: 2025]
Secondary outcome measures (1)
  • Lordosis angle by means of arrow test [Time frame: 2025]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Spain · 1 center
  • University of Alcalá — Alcalá de Henares

Identifiers

NCT: NCT05733377 · Pregnant women´s lordosis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗