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

NCT05733377 | Recruiting DMC

• 1 other identifier: Pregnant women´s lordosis
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Lordosis angle using an app

  Differentiation between lordosis, hyperlordosis and lumbar rectification

  2025

Secondary Outcomes (1)

• Lordosis angle by means of arrow test

  2025

Study Arms (1)

Pregnant

Pregnant \>36 weeks gestation, 20 to 40 years old, without significant lumbar pathology, or intense labor pain, or percentile p\>97 or \<p3, or with a result of delivery-cesarean section due to risk of loss of fetal well-being

Diagnostic Test: Arrow Test; Diagnostic Test: Angle measurement by imaging device

Interventions

Arrow Test DIAGNOSTIC_TEST

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

Pregnant

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.

Pregnant

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women are being monitored by the Fuenlabrada Hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead
• Hospital Universitario de Fuenlabrada: collaborator

Study Sites (1)

University of Alcalá

Alcalá de Henares, Madrid, 28871, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 17, 2023
• Study Start: July 15, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)