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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05733377
Enrollment
122
Registered
2023-02-17
Start date
2022-07-15
Completion date
2025-06-30
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Disorder, Biomechanics, Biomedical Technology, Diagnostic Imaging, Pregnancy Outcome

Brief summary

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_TESTArrow Test

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

DIAGNOSTIC_TESTAngle 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 measured with this image and the software.

Sponsors

Hospital Universitario de Fuenlabrada
CollaboratorOTHER
University of Alcala
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lordosis angle using an app2025Differentiation between lordosis, hyperlordosis and lumbar rectification

Secondary

MeasureTime frameDescription
Lordosis angle by means of arrow test2025Differentiation between lordosis, hyperlordosis and lumbar rectification.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026