Assessment of Bone Mineral Density During Pregnancy | NCT02480023

Studies
Assessment of Bone Mineral Density During Pregnancy

NCT02480023

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 12, 2016Estimated

Enrollment

173Actual

Phase

Phase 1

Conditions

Bone Mineral Density Quantitative Trait Locus 3

Interventions

calcaneal quantitative ultrasound assessment

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jun 19, 2015

First Submission Date that Met QC Criteria

Jun 23, 2015

First Posted Date

Jun 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthcare	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	healthcare

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohamed laban, MD	Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine, ain shams university		Cairo	Cairo Governorate		Egypt