Physical Activity and Gestational Complications | NCT02343848

Studies
Physical Activity and Gestational Complications

NCT02343848

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Apr 24, 2018Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Pregnancy

Interventions

smart bracelet.

Countries

Israel

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jan 2019Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Jan 16, 2015

First Submission Date that Met QC Criteria

Jan 21, 2015

First Posted Date

Jan 22, 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

Apr 21, 2018

Last Update Posted Date

Apr 24, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Shalom Mazaki-Tovi MD, Directore , HR Unit, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The association between physical activity and several complication of pregnancy will be evaluated .

Detailed Description

The association between physical activity and several complication of pregnancy will be evaluated. Patients with complications of pregnancy will be recruited. Physical activity will be evaluated using questioner or smart bracelet.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Experimental	smart bracelet.	Device: smart bracelet.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
smart bracelet.	Device	Physical activity will be evaluated using smart bracelet.	treatment

Measure	Description	Time Frame
Presence of Gestational Complication		40 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women

Exclusion Criteria:

Non pregnant women

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shalom Mazaki tovi	Recruiting	Ramat Gan			Israel