Longitudinal Study of Intra-Uterine Growth Restriction
The investigation will employ a longitudinal approach in which every fetus diagnosed to be SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta over time. These findings will be correlated with neurological and cardiovascular function in the newborn and early childhood. This research initiative should yield diagnostic and therapeutic templates that will improve the quality of life of IUGR babies in addition to providing important information that will better inform current diagnostic practices.
Conditions:
🦠 IUGR 🦠 Pregnancy
🗓️ Study Start (Actual) April 2015
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 200
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients with diagnosed SGA by an ultrasound estimated fetal weight (EFW) of less than the 10th percentile or a fetal abdominal circumference of less than the 5th percentile will be included in the study at the time of their first examination.

    Exclusion Criteria:

    • * Patients \< 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 March 2015
  • First Submitted that Met QC Criteria 2 March 2015
  • First Posted 9 March 2015

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 May 2024
  • Last Update Posted 10 May 2024
  • Last Verified May 2024