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NCT02510170 Clinical Trial

Fetal and Maternal Head Circumference During Pregnancy in Israeli Population

Maternal-Fetal Relations Clinical Trial

Official title:
Fetal and Maternal Head Circumference During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02510170
Other study ID # COM150035CTIL
Secondary ID
Status Completed
Phase N/A
First received July 19, 2015
Last updated February 12, 2017
Start date September 2015
Est. completion date July 2016

Study information
Verified date January 2016
Source Clalit Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 188
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention

Locations
Country Name City State
Israel Women's Health Center - Lev Tel-Aviv Tel-Aviv

Sponsors (1)
Lead Sponsor Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fetal head circumference (millimeters) Israeli fetal population. Will be reported in table and / or graph form 14 through 40 weeks pregnancy
Secondary 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
Secondary Maternal head circumference (millimeters) Israeli maternal population. Will be reported in table and / or graph form age 18 through 40
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