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Fetal and Maternal Head Circumference During Pregnancy in Israeli Population

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ClinicalTrials.gov Identifier: NCT02510170
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Clalit Health Services

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.

Condition or disease Intervention/treatment
Maternal-Fetal Relations Microcephaly Other: no intervention

Study Type : Observational [Patient Registry]
Actual Enrollment : 188 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Fetal and Maternal Head Circumference During Pregnancy
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016





Primary Outcome Measures :
  1. Fetal head circumference (millimeters) [ Time Frame: 14 through 40 weeks pregnancy ]
    Israeli fetal population. Will be reported in table and / or graph form


Secondary Outcome Measures :
  1. Relationship of fetal head circumference (mm) to maternal head circumference (mm) [ Time Frame: 14 through 40 weeks pregnancy where applicable ]
    Calculating effect of maternal head circumference on fetal head circumference during pregnancy and adjusting (Formula) fetal head circumference normal values (+/- 2SD)

  2. Maternal head circumference (millimeters) [ Time Frame: age 18 through 40 ]
    Israeli maternal population. Will be reported in table and / or graph form



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510170


Locations
Israel
Women's Health Center - Lev Tel-Aviv
Tel-Aviv, Israel
Sponsors and Collaborators
Clalit Health Services

Responsible Party: Clalit Health Services
ClinicalTrials.gov Identifier: NCT02510170     History of Changes
Other Study ID Numbers: COM150035CTIL
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: January 2016

Keywords provided by Clalit Health Services:
Fetus
Skull
ultrasonography

Additional relevant MeSH terms:
Microcephaly
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities