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

Recruiting

• Conditions: Back Disorder; Pregnancy Outcome; Diagnostic Imaging; Biomechanics; Biomedical Technology
• Interventions: Diagnostic Test: Arrow Test; Diagnostic Test: Angle measurement by imaging device

• Registration Number: NCT05733377
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant	Arrow Test	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
Pregnant	Angle measurement by imaging device	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

Primary Outcome Measures

Name	Time	Method
Lordosis angle using an app	2025	Differentiation between lordosis, hyperlordosis and lumbar rectification

Secondary Outcome Measures

Name	Time	Method
Lordosis angle by means of arrow test	2025	Differentiation between lordosis, hyperlordosis and lumbar rectification.

Trial Locations

Locations (1)

University of Alcalá; 🇪🇸 Alcalá De Henares, Madrid, Spain