Status:
COMPLETED
Placenta Imaging Project
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
High Risk Pregnancy
Eligibility:
FEMALE
18-52 years
Brief Summary
The purpose of this study is to test the application of newly generated magnetic resonance imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The primary objective is...
Detailed Description
The placenta provides all the nutrition from a pregnant mother to a developing fetus. A placenta that functions normally is needed to ensure normal fetal growth and development. Unfortunately, the pla...
Eligibility Criteria
Inclusion
- Pregnant women will be recruited based on inclusion criteria for 3 subject groups:
- Non-smokers with low risk for placental insufficiency
- Smokers
- Non-smokers who are at a high risk for adverse outcomes based on prior clinical history.
- Inclusion criteria: Pregnant women fulfilling inclusion criteria, and not meeting exclusion criteria, will be invited to participate in this study.
- Inclusion criteria for all groups:
- Maternal age over 18 years and able to give informed consent
- Pregnant patient, as defined by positive pregnancy test for elevated β-human chorionic gonadotropin (HCG) and certain menstrual history, or early ultrasound, identified prior to 14 weeks of gestation
- Inclusion criteria for low risk group:
- No history of a second or third trimester loss
- No history of fetal growth restriction
- Inclusion criteria for high risk group:
- History of pregnancy complicated by placental insufficiency in a previous singleton pregnancy (i.e. severe preeclampsia requiring preterm delivery, preterm delivery due to placenta insufficiency (eg. fetal growth restriction (FGR), oligohydramnios, abnormal umbilical artery Doppler's, abnormal antenatal testing), FGR \<10% delivered at term; stillbirth attributed to placental cause, regardless of gestational age
- Not currently a smoker
- Pregnancy at risk for placental insufficiency due to clinical concerns (eg. chronic hypertension)
- Spontaneous preterm birth \<34 weeks
- Exclusion criteria: These criteria will exclude women whose medications, personality traits or obstetric conditions could confound their ability to complete a 1 hour MRI scan.
- Individuals with intellectual disability or who are incarcerated
- Multiple gestation
- Major fetal anomalies known to be associated with abnormal growth (i.e. major congenital heart defect, gastroschisis)
- Current maternal history of alcohol or illicit drug use
- Current medical problems requiring chronic treatment:
- Cancer
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
- Chronic pulmonary disease including asthma requiring regular use of medication
- Prior history of claustrophobia
- Metal implants
- Increased aneuploidy risk based on ultrasound findings or genetic testing
Exclusion
Key Trial Info
Start Date :
October 13 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT02749851
Start Date
October 13 2016
End Date
June 30 2020
Last Update
October 5 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health and Science University
Portland, Oregon, United States, 97239
2
University of Utah
Salt Lake City, Utah, United States, 84112