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

Sponsor

University of Alcala (Other)

Overall Status

Recruiting

CT.gov ID

NCT05733377

Collaborator

Hospital Universitario de Fuenlabrada (Other)

122

Enrollment

Location

35.5

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Outcome Biomechanics Back Disorder Diagnostic Imaging Biomedical Technology	Diagnostic Test: Arrow Test Diagnostic Test: Angle measurement by imaging device

Study Design

Study Type:

Observational

Anticipated Enrollment :

122 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 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 measured with this image and the software.

Arm

Intervention/Treatment

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

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 measured with this image and the software.

Outcome Measures

Primary Outcome Measures

Lordosis angle using an app [2025]
Differentiation between lordosis, hyperlordosis and lumbar rectification

Secondary Outcome Measures

Lordosis angle by means of arrow test [2025]
Differentiation between lordosis, hyperlordosis and lumbar rectification.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alcalá	Alcalá De Henares	Madrid	Spain	28871

Sponsors and Collaborators

University of Alcala
Hospital Universitario de Fuenlabrada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Susana Nunez Nagy, Professor, PhD, University of Alcala

ClinicalTrials.gov Identifier:

NCT05733377

Other Study ID Numbers:

Pregnant women´s lordosis

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lordosis

Swayback

Study Results

No Results Posted as of Feb 21, 2023