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OpenTrials
Completed

NCT Number: NCT02480023

Assessment of Bone Mineral Density During Pregnancy

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

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Key information

Conditions

Bone Mineral Density Quantitative Trait Locus 3

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of medicine, ain shams university

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • females during 3rd trimister

Exclusion criteria

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

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

Treatment and study plan

calcaneal quantitative ultrasound assessment

Radiation

QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester

Primary outcomes

  1. Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Changes in Bone Mineral Density as Measured by Calcaneal Quantitative Ultrasound in Third Trimester of Pregnancy

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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