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Status:

COMPLETED

Fetal Growth Evaluation by Three-Dimensional Ultrasound

Lead Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

Pregnancy

Eligibility:

FEMALE

Brief Summary

Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an important cause for increased perinatal mortality in the United States. Toward this end, accurate fetal weigh...

Detailed Description

Fetal growth abnormalities, such as macrosomia and intrauterine growth retardation, are an important cause for increased perinatal mortality in the United States. Toward this end, accurate fetal weigh...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • ALL SUBJECTS:
  • Pregnant women between the ages of 18 and 40 years at Hutzel and William Beaumont Hospital sites.
  • LOGITUDINAL ARM:
  • Single gestation.
  • No pregnancy complications.
  • Accurate dating criteria (sure LMP or first trimester scan).
  • CROSS-SECTIONAL ARM OF PROTOCOL:
  • Singe Gestation.
  • No pregnancy complications.
  • Accurate data criteria (sure LMP or 1st trimester scan).
  • Delivery anticipated within 4 days of scan.
  • INFANT BODY COMPOSITION STUDY
  • Birthweight above 1,000 grams
  • EXCLUSION CRITERIA:
  • LONGITUDINAL ARM OF PROTOCOL:
  • Poor visualization of the fetus due to technical factors (e.g. obesity).
  • Risk factors that increase risk for not keeping serial ultrasound appointments.
  • CROSS-SECTIONAL ARM OF PROTOCOL:
  • Poor visualization of the fetus due to technical factors (e.g. obesity).
  • Hemodynamically unstable patients.
  • INFANT BODY COMPOSITION STUDY
  • Infants requiring mechanical ventilation, heart monitors, or intravenous fluid.
  • Hemodynamically unstable infant
  • Infants with thermoregulation problems

Exclusion

    Key Trial Info

    Start Date :

    December 4 1997

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 5 2012

    Estimated Enrollment :

    1919 Patients enrolled

    Trial Details

    Trial ID

    NCT00340171

    Start Date

    December 4 1997

    End Date

    November 5 2012

    Last Update

    February 24 2023

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Hutzel Women's Hospital

    Detroit, Michigan, United States, 48201

    2

    William Beaumont Hospital

    Royal Oak, Michigan, United States