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.
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)
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
Parallel
bone densitometric examination using REMS technology
DeviceAn assessment of bone health using ultrasound densitometry using REMS technology, integrated into the EchoStation device (Echolight Spa, Lecce, Italy), is performed during the third trimester check-up. Thanks to an innovative parameter called Fragility Score (FS), intrinsically correlated with bone quality and independent of BMD, REMS allows assessment of bone fragility and its resulting fracture risk, representing a useful diagnostic tool also in predicting the risk of fragility fractures.
questionnaires
Other interventionSpecific questionnaires developed by the Fragility Fracture Observatory (OFF) will be administered. Their purpose is to assess all risk factors that could lead to fractures during pregnancy, as well as to evaluate both dietary habits and adherence to the Mediterranean diet
BMD differences between singleton and twin pregnancies
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 a singleton pregnancy and women with dichorionic and monochorionic twin pregnancies.
BMD values and maternal clinical parameter
Evaluation of the correlation between bone mineral density (BMD), measured by dual-energy X-ray absorptiometry (DEXA) and expressed in g/cm², and the following maternal clinical parameters: body mass index (BMI, kg/m²) maternal age (years) weight gain during pregnancy (kg) The correlation will be analyzed using a correlation coefficient (Pearson or Spearman, depending on the data distribution).
Correlation between bone mineral density (DEXA, g/cm²) and validated questionnaire scores (calcium intake, PREDIMED, AFEF)
Evaluation of the correlation between bone mineral density (BMD) values, measured by dual-energy X-ray absorptiometry (DEXA) and expressed in g/cm², and: * daily dietary calcium intake, assessed using a dedicated questionnaire and expressed in mg/day * adherence to the Mediterranean diet, assessed using the PREDIMED questionnaire and expressed as a total score * individual risk, assessed using the AFEF questionnaire and expressed as a total score The correlation will be analyzed using a correlation coefficient (Pearson or Spearman, depending on the data distribution)
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