Pregnancy OutcomeNCT05733377
Non-invasive Imaging Technique for the Study of Lordosis in Pregnant Women and Its Relationship to Birth Outcome
An observational study of Pregnancy Outcome and Biomechanics, run by University of Alcala at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Outcome, Biomechanics, Back Disorder
- What is being tested?
- Arrow Test and Angle measurement by imaging device
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women are being monitored by the Fuenlabrada Hospital.
Who may be able to join
- pregnant women between 20 and 40 years old with a low-risk pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Alcalá
Alcalá de Henares, Madrid, 28871
Susana N Núñez Nagy, PhD, 0034918852524, susana.nunez@uah.es
About this study
Official title: Validation of a Non-invasive Image Technique for Studying Pregnant Women´s Lordosis. Relation Between Lordosis and Childbirth Outcome.
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.
- Being tested
- Arrow Test, Angle measurement by imaging device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrow TestDiagnostic 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 deviceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Arrow Test; Diagnostic Test: Angle measurement by imaging device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lordosis angle using an app
Differentiation between lordosis, hyperlordosis and lumbar rectification
Measured: 2025
Secondary outcomes (1)
Lordosis angle by means of arrow test
Differentiation between lordosis, hyperlordosis and lumbar rectification.
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start15 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada
- Responsible party
- Principal investigator, Susana Nunez Nagy, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733377
- Sponsor's protocol ID
- Pregnant women´s lordosis
- Status last verified
- Nov 2024
- First submitted
- 30 Jan 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Non-invasive Image Technique for Studying Pregnant Women´s Lordosis. Relation Between Lordosis and Childbirth Outcome.
- ClinicalTrials.gov ID
- NCT05733377
- Acronym / sponsor ID
- Pregnant women´s lordosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- Hospital Universitario de Fuenlabrada
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant | – | Diagnostic Test: Arrow Test, Diagnostic Test: Angle measurement by imaging devicePregnant >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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women are being monitored by the Fuenlabrada Hospital.
Key inclusion criteria (1 listed)
- pregnant women between 20 and 40 years old with a low-risk pregnancy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arrow TestIt consists of taking the widest measurement between the rope of a plumb bob on her upper and lower back. | Diagnostic test | Pregnant |
| Angle measurement by imaging deviceFirst, 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. | Diagnostic test | Pregnant |
Primary outcome
Lordosis angle using an app
Time frame: 2025
Differentiation between lordosis, hyperlordosis and lumbar rectification
1 secondary outcome
Lordosis angle by means of arrow test
Time frame: 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Outcome and Biomechanics, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lordosis angle using an app (time frame: 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.