Actively Recruiting
Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-04-02
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study aims to monitor and evaluate bone mineral density and fracture risk in women with singleton and twin pregnancies through the combined use of: * two specific questionnaires developed by the Fragility Fracture Observatory (OFF), and * a bone densitometric examination using REMS technology, performed between the 35th and 41st week of gestation. Primary objective: • To identify, in the third trimester of pregnancy (between the 35th and 41st gestational week), any differences in bone mineral density (BMD) between women with singleton pregnancies and women with dichorionic and monochorionic twin pregnancies. Secondary objectives: * Evaluate the relationship between bone mineral density (BMD) values and maternal clinical and historical parameters, such as age, body mass index (BMI), and obstetric and medical history. * Evaluate the association between BMD values and scores obtained from validated questionnaires administered to investigate fracture risk and bone health-related quality of life in women with singleton and twin pregnancies.
CONDITIONS
Official 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 in the study and ability to complete the study questionnaires
- Women between 35 and 41 weeks of gestational age at the time of study inclusion
- Singleton or twin pregnancy (dichorionic or monochorionic)
- Age between 30 and 45 years at the time of study recruitment
- No history of recent or previous bone fractures or traumatic fractures, and no motor disabilities (in the mother)
- Absence of a diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS)
- No intake of vitamin D or other medications during pregnancy
- Absence of current or previous conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver disease)
- Women of normal weight or with class I obesity (BMI between 18.5 and 34)
You will not qualify if you...
- Failure to sign the informed consent form
- Poor compliance and/or inability to complete the study questionnaires
- Women with previous or newly diagnosed comorbidities during pregnancy
- Age <30 and >45 years
- Previous diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS)
- BMI <18.5 or >34
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy, 00168
Actively Recruiting
Research Team
T
Tullio Ghi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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