Status:
COMPLETED
Placental Lesions in Fetal Growth Restrictions
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Fetal Growth Retardation
Eligibility:
FEMALE
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to develop imaging methods to diagnose placental injury in pregnancies diagnosed with fetal growth restriction (FGR). Investigators are doing this research becaus...
Detailed Description
Research Procedure Descriptions Blood/urine collection for research Blood and urine samples are collected at the consenting visit and at the time of delivery. A total of 10 mL, of blood is collected ...
Eligibility Criteria
Inclusion
- Pregravid Body Mass Index (BMI) 18.5-39.9 kg/M2
- Women with singleton pregnancies
- Ultrasound confirmed pregnancy dating prior to 14 weeks gestation
- Gestational age of 27 0/7 - 32 6/7 weeks at FGR diagnosis based on standard clinical criteria: Either estimated fetal weight (EFW) less than 10 percentile OR abdominal circumference less than 10th percentile
Exclusion
- Diagnosis of preeclampsia at FGR diagnosis
- Gestational Diabetes Mellitus or type I/II Diabetes Mellitus
- Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy
- Known fetal viral infection syndrome
- Alcohol/drug use in current pregnancy
- History of sickle cell anemia, sickle cell trait or other inherited anemia with risk of iron overload
- Contraindications to MRI (such as claustrophobia, metallic implant, etc.) based on MRI Screening
- Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
- Any physical or psychological symptom, based on the clinical judgment of the study physician that would make a participant unsuitable for the study.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04839185
Start Date
April 15 2021
End Date
October 6 2021
Last Update
August 22 2025
Active Locations (1)
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1
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53715