Assessment of Bone Mineral Density During Pregnancy

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

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

Study Overview

• Status: Completed
• Conditions: Bone Mineral Density Quantitative Trait Locus 3
• Intervention / Treatment: Radiation: calcaneal quantitative ultrasound assessment

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
• Enrollment (Actual): 173
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Al Qahirah
    • Cairo, Al Qahirah, Egypt
      • Faculty of Medicine, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis.	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: mohamed laban, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 9, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: osteopenia during pregnancy