Actively Recruiting

Phase Not Applicable
Age: 30Years - 45Years
FEMALE
Healthy Volunteers
ID07508553

Pregnancy-associated Reduction in Bone Mineral Density: a Comparative Study Using REMS Technology Between Singleton and Twin Pregnancies in the Third Trimester

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-04-02

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating bone mineral density (BMD) and fracture risk in women with singleton and twin pregnancies during the third trimester. The study aims to identify differences in BMD between these groups and assess the relationship between BMD and maternal factors like age, body mass index (BMI), and medical history. It also investigates how BMD correlates with scores from specific questionnaires related to fracture risk and bone health quality of life. Women between 35 and 41 weeks of pregnancy will complete two questionnaires developed by the Fragility Fracture Observatory (OFF) that assess fracture risk, dietary calcium intake, and adherence to the Mediterranean diet. Bone health will be evaluated using a radiation-free ultrasound densitometry technology called REMS, performed with the EchoStation device. This device measures bone density and fragility through a 40-second ultrasound scan of the femoral neck, providing results similar to a DEXA scan but without radiation exposure. Participants will provide their medical, obstetric, and dietary history and complete questionnaires during enrollment. Bone density and fragility will be monitored during the third trimester. Researchers will analyze BMD differences, maternal clinical parameters, and questionnaire results over about six weeks until delivery. The study includes detailed bone assessments, lifestyle evaluations, and maternal health monitoring to better understand bone health changes during pregnancy in both singleton and twin pregnancies.

CONDITIONS

Brief Title

Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination

Who Can Participate

Age: 30Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Willingness to participate and ability to complete study questionnaires
  • Women between 35 and 41 weeks of gestational age
  • Singleton or twin pregnancy (dichorionic or monochorionic)
  • Age between 30 and 45 years
  • No history of recent or previous bone fractures or motor disabilities
  • No diagnosis of osteopenia or osteoporosis per Italian Society criteria
  • No intake of vitamin D or other medications during pregnancy
  • No current or previous conditions affecting bone metabolism (e.g., thyroid, kidney, liver disease)
  • Normal weight or class I obesity (BMI between 18.5 and 34)
Not Eligible

You will not qualify if you...

  • Failure to sign informed consent
  • Poor compliance or inability to complete questionnaires
  • Previous or newly diagnosed comorbidities during pregnancy
  • Age below 30 or above 45 years
  • Previous diagnosis of osteopenia or osteoporosis per Italian Society criteria
  • BMI below 18.5 or above 34

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 6 weeks (from enrollment through delivery)

Participants complete specific questionnaires assessing fracture risk and dietary habits, and undergo an ultrasound bone densitometric examination using REMS technology during the third trimester check-up to evaluate bone health and fracture risk.

1 visit (in-person) during the third trimester

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy, 00168

Actively Recruiting

Loading map...

Research Team

T

Tullio Ghi

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Similar Trials

Development and Validation of a Prediction Model for Adverse...

Aplastic Anemia

Actively Recruiting

1 location

A Prospective Observational Study Using AI and 3D Imaging to...

Vertebral Fracture

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here