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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-45
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • bone densitometric examination using REMS technology
  • questionnaires

Treatment groups

100 Participants
are divided into 2 treatment groups