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Assessment of Bone Mineral Density During Pregnancy

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ClinicalTrials.gov Identifier: NCT02480023
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
dr mohamed laban, Ain Shams University

Brief Summary:
BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.

Condition or disease Intervention/treatment Phase
Bone Mineral Density Quantitative Trait Locus 3 Radiation: calcaneal quantitative ultrasound assessment Phase 1

Detailed Description:
Consecutive patients with singleton pregnancies between 36 and 39 weeks booked at a general obstetric clinic in a regional hospital will be recruited for the study. The obstetric department is a tertiary referral center in the region and part of a university teaching unit which catered to an annual delivery of around 10,000 women. A group of first trimester pregnant women with nearly the same age is recruited as controls.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Changes in Bone Mineral Density as Measured by Calcaneal Quantitative Ultrasound in Third Trimester of Pregnancy
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: healthcare
QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester
Radiation: calcaneal quantitative ultrasound assessment
QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester



Primary Outcome Measures :
  1. Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis. [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. females during 3rd trimister

Exclusion Criteria:

  1. Secondary causes of bone loss such as hyperparathyroidism.
  2. Co-morbidities that would interfere with bone metabolism as clinically significant liver or renal disease.
  3. Physical or orthopedic disabilities that would place the subject at risk or limit their ability to perform US.
  4. Taking medication known to affect bone including steroid hormones.

Histories of smoking and use of oral contraceptives (OCs) are not exclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480023


Locations
Egypt
Faculty of medicine, ain shams university
Cairo, Al Qahirah, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
Study Chair: mohamed laban, MD Ain Shams University

Responsible Party: dr mohamed laban, Prof. Mohamed Laban, Ain Shams University
ClinicalTrials.gov Identifier: NCT02480023     History of Changes
Other Study ID Numbers: osteopenia during pregnancy
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases