Fetal and Maternal Head Circumference During Pregnancy in... | NCT02510170

Studies
Fetal and Maternal Head Circumference During Pregnancy in Israeli Population

NCT02510170

Sponsor

Clalit Health Services

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

188Actual

Phase

Not provided

Conditions

Maternal-Fetal Relations
Microcephaly

Interventions

no intervention

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

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

Sep 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 19, 2015

First Submission Date that Met QC Criteria

Jul 26, 2015

First Posted Date

Jul 29, 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

Feb 12, 2017

Last Update Posted Date

Feb 14, 2017Actual

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

In this study, measurements of fetal and maternal head circumference will be collected. This data will be presented in table or graph form. The effect of maternal head circumference on fetal head circumference will be evaluated and presented in either formula or graph form.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

188Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fetal head circumference (millimeters)	Israeli fetal population. Will be reported in table and / or graph form	14 through 40 weeks pregnancy

Secondary Outcomes

Measure	Description	Time Frame
Relationship of fetal head circumference (mm) to maternal head circumference (mm)	Calculating effect of maternal head circumference on fetal head circumference during pregnancy and adjusting (Formula) fetal head circumference normal values (+/- 2SD)	14 through 40 weeks pregnancy where applicable
Maternal head circumference (millimeters)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancy
Valid first trimester sonogram

Exclusion Criteria:

Women under 18 years of age
Women over 40 years of age
Multi fetal pregnancy
No accurate dating of pregnancy age
Participant non compliance or cannot complete contact details
Technical difficulty measuring fetal or maternal skull
Abnormal fetal or maternal skull
Familial hereditary disease, mental retardation
Chronic maternal illness
Maternal on chronic medication
Abnormal screening test during current pregnancy
Abnormal sugar metabolism or Hypertension during current pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Health Center - Lev Tel-Aviv		Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D008831	Microcephaly

Ancestor Terms

ID	Term
D019465	Craniofacial Abnormalities
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D065703	Malformations of Cortical Development, Group I

Browse Leaves

Not provided

Browse Branches

Not provided