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Official title Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination
ClinicalTrials.gov ID: NCT07508553
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Patients will not be included in the study if at least one of the following exclusion criteria is met:
- 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 \ 45 years
- Previous diagnosis of osteopenia or osteoporosis according to the criteria of the Italian Society for Osteoporosis, Mineral Metabolism and Bone...
See the full eligibility criteria
- 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).
- Patients will not be included in the study if at least one of the following exclusion criteria is met:
- 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 \ 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 \ 34
The study team makes the final eligibility decision.
Where it's taking place
- Roma, RM, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, RM, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.