NCT02510170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

July 19, 2015

Last Update Submit

February 12, 2017

Conditions

Maternal-Fetal RelationsMicrocephaly

Keywords

FetusSkullultrasonography

Outcome Measures

Primary Outcomes (1)

  • Fetal head circumference (millimeters)

    Israeli fetal population. Will be reported in table and / or graph form

    14 through 40 weeks pregnancy

Secondary Outcomes (2)

  • Relationship of fetal head circumference (mm) to maternal head circumference (mm)

    14 through 40 weeks pregnancy where applicable

  • Maternal head circumference (millimeters)

    age 18 through 40

Interventions

no interventionOTHER

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Singleton pregnancy
  • Valid first trimester sonogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Center - Lev Tel-Aviv

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Microcephaly

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2015

First Posted

July 29, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 14, 2017

Record last verified: 2016-01

Locations

IL(1)