Status:
RECRUITING
MRI Assessment of Placental Health
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Massachusetts Institute of Technology
Conditions:
Intrauterine Growth Restriction
Eligibility:
FEMALE
18-45 years
Brief Summary
The ultimate goal of this project is to develop methods that allow informed decision-making on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In placenta related IU...
Eligibility Criteria
Inclusion
- The pregnant mother with twin gestation with diagnosis of selective IUGR based upon obstetrical US findings as following:
- Proven monochorionicity / dichorionicity
- Discordance in estimated fetal weight (EFW). Growth restriction (\<10 percentile of norm) in one or both fetus(es) AND/OR growth discordance (\> or = 20%) between twin fetuses.
- The pregnant mother with singleton gestation with diagnosis of IUGR based upon obstetrical US findings as following:
- Proven singleton gestation
- Growth restriction of fetus (\<10 percentile of norm)
- Doppler measurements that indicates placental insufficiency: umbilical artery, middle cerebral artery, uterine artery; or oligohydramnios.
- Gestational age: Bigger than 18 weeks.
- Pregnant mother is between age 18 to 45, clinically stable and can safely tolerate fetal MRI study.
Exclusion
- Fetuses/infants with the following features will be excluded.
- Fetus/infant with chromosomal anomalies or known genetic disorders.
- Fetus/infant with other major congenital malformation.
- Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient, quality or completeness of the data.
- Pregnant mothers with the following features will be excluded.
- Mothers with contraindication to MRI (with pacemaker, metal in body, oversize).
- Mothers with claustrophobia
- Mothers medically unstable for the MRI study
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02297724
Start Date
April 1 2014
End Date
September 1 2028
Last Update
December 12 2025
Active Locations (2)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942