Actively Recruiting
MRI Assessment of Placental Health in Pregnant Women with Intrauterine Growth Restriction
Led by Boston Children's Hospital · Updated on 2025-12-12
80
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating ways to improve decision-making about when to deliver babies at higher risk of stillbirth due to intrauterine growth restriction (IUGR). IUGR is linked to problems with the placenta that reduce the supply of oxygen and nutrients to the fetus. This study aims to use MRI scans to measure how well oxygen and blood flow are transported in the placenta, helping to better identify pregnancies with placental problems. The researchers will also explore other MRI techniques to assess placental health. Participants will undergo MRI scans where oxygen is given through a mask at a flow rate of 15 liters per minute for up to 10 minutes during each scan. Data collection starts about 10 minutes before oxygen administration, continues through the oxygen exposure, and lasts about 10 minutes afterward. These measurements will help assess placental function in real time. During the study, the team will measure changes in MRI signals related to oxygen levels and placental size. After birth, placental tissue will be examined, and the baby's growth will be tracked for up to six months. The study involves pregnant women aged 18 to 45 with certain types of pregnancies affected by IUGR, and safety will be closely monitored throughout. Participation may last one hour per scan, with follow-up on fetal health after delivery.
CONDITIONS
Brief Title
MRI Assessment of Placental Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with twin gestation diagnosed with selective IUGR based on ultrasound findings, including proven chorionicity and fetal weight discordance or growth restriction below the 10th percentile
- Pregnant women with singleton gestation diagnosed with IUGR by ultrasound showing fetal growth restriction below the 10th percentile and placental insufficiency indicated by Doppler measurements or low amniotic fluid
- Gestational age greater than 18 weeks
- Age between 18 and 45 years, clinically stable and able to safely tolerate fetal MRI study
You will not qualify if you...
- Fetuses or infants with chromosomal anomalies or known genetic disorders
- Fetuses or infants with major congenital malformations
- Any condition that may compromise patient safety or data quality as judged by the investigator
- Pregnant women with contraindications to MRI such as pacemakers, metal implants, or large body size
- Pregnant women with claustrophobia
- Pregnant women who are medically unstable for MRI study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 hour per scan
Participants undergo MRI scans to assess placental health during pregnancy, including oxygen administration during the scan.
1 MRI scan visit (in-person)
Duration - Up to 6 months after delivery
Participants' placental pathology reports are reviewed after delivery, and fetal growth is monitored up to 6 months after birth.
Follow-up visits as needed up to 6 months
Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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