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Pregnancy's hidden strain: measuring the Back's inner support tissue

NCT ID NCT05335330

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This study measures how the thoracolumbar fascia — a sheet of connective tissue in the lower back — changes during pregnancy. Researchers will take non-invasive measurements of tissue stiffness, tone, and elasticity in first-time mothers during each trimester. The goal is to establish normal values and better understand how the body adapts to pregnancy-related changes in the lumbopelvic region.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could establish normal ranges for back tissue properties in pregnancy, helping to identify abnormal changes that may contribute to back pain.
What could go wrong
This is a small, early observational study. It does not test any treatment, and the findings may not apply to women with multiple pregnancies or pre-existing conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

145 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women (first pregnancy)

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * First pregnancy * They are between the ages of 18-40 * Pre-pregnancy Body-Mass-Index (BMI) \< 30 kg/m2 Exclusion Criteria: * Presence of connective tissue disease * Deterioration of skin integrity in measurement areas * Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal in biomechanical alignment * History of spine, pelvis or lower extremity surgery or fracture in the past 6 months * Description of chronic (more than 3 months) lumbar-pelvic region pain before pregnancy * Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia * Having Pelvic Girdle Pain

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • İstanbul Medeniyet University

    Istanbul, Turkey (Türkiye)

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