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

RecruitingNAAges 30 Years - 45 YearsFemaleFondazione Policlinico Universitario Agostino Gemโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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: โ€ข 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 sco

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
INCLUSION CRITERIA 1. Signed informed consent 2. Willingness to participate in the study and ability to complete the study questionnaires 3. Women between 35 and 41 weeks of gestational age at the time of study inclusion 4. Singleton or twin pregnancy (dichorionic or monochorionic) 5. Age between 30 and 45 years at the time of study recruitment 6. No history of recent or previous bone fractures or traumatic fractures, and no motor disabilities (in the mother). 7. Absence of a diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS). 8. No intake of vitamin D or other medications during pregnancy. 9. Absence of current or previous conditions that could potentially interfere with bone metabolism (e.g., thyroid, kidney, or liver disease). 10. Women of normal weight or with class I obesity (BMI between 18.5 and 34). EXCLUSION CRITERIA Patients will not be included in the study if at least one of the following exclusion criteria is met: 1. Failure to sign the informed consent form 2. Poor compliance and/or inability to complete the study questionnaires 3. Women with previous or newly diagnosed comorbidities during pregnancy 4. Age \<30 and \>45 years 5. Previous diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS) 6. BMI \<18.5 or \>34
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What it tests

  • bone densitometric examination using REMS technology
  • questionnaires
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Where

1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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