Actively Recruiting
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
Eligibility Criteria
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)
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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