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

NCT ID: NCT05733377

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2025-06-30

Brief Summary

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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

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Conditions

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Pregnancy Outcome Biomechanics Back Disorder Diagnostic Imaging Biomedical Technology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Arrow Test

Intervention Type DIAGNOSTIC_TEST

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

Angle measurement by imaging device

Intervention Type 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.

Interventions

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Arrow Test

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario de Fuenlabrada

OTHER

Sponsor Role collaborator

University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Susana Nunez Nagy

Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alcalá

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Susana N Núñez Nagy, PhD

Role: primary

0034918852524

Other Identifiers

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Pregnant women´s lordosis

Identifier Type: -

Identifier Source: org_study_id

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