MRI Assessment of Placental Health
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|ClinicalTrials.gov Identifier: NCT02297724|
Recruitment Status : Recruiting
First Posted : November 21, 2014
Last Update Posted : August 11, 2022
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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 IUGR pregnancies, there can be multiple concurrent placental pathologies. Although there is no specific correspondence between a single type of pathology and IUGR, the common result of these pathologies is placental insufficiency, which limits the maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and inflammation in the villous and intervillous space (villitis). Thus one potential approach to distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental transport. Based on the hypothesis that efficiency of oxygen transport is representative for overall oxygen and nutrition transport in placenta, the investigators propose to characterize the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use it as an index for better stratification in the IUGR risk group. The investigators will also consider alternative MRI approaches such as structural, diffusion and spectroscopy measurements inside the placenta, which might reflect the state of placental transport and reveal the status of placental health.
Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency from normal placenta transport with histopathology data of the placenta. 2) To correlate the MRI metrics that reflects placental insufficiency with fetal outcome
|Condition or disease||Intervention/treatment|
|Intrauterine Growth Restriction||Other: Oxygen|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||MRI Assessment of Placental Health|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2025|
For all subjects, administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan. Data collection will start about 10 min before the administration of oxygen, and last throughout the oxygen exposure, then continue for about 10 min after oxygen exposure for each subject.
Administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan.
- BOLD MRI signal change during maternal oxygen exposure in placenta and fetus [ Time Frame: 30 min during the 1 hour scan ]
- placental volume on MRI image [ Time Frame: 5 min during 1 hour scan ]
- pathological reports of placenta after delivery [ Time Frame: 1 day ]
- fetal growth curve after birth [ Time Frame: up to 6 month ]
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- pregnant mothers with twin gestation with diagnosis of selective IUGR
- pregnant mothers with singleton gestation with diagnosis of IUGR
- singleton pregnant mothers and twin pregnant mothers with no apparent medical complication on fetuses
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297724
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Patricia E Grant, MD 857-218-5111 firstname.lastname@example.org|
|Hospital Universitario de Fuenlabrada||Recruiting|
|Madrid, Spain, 28942|
|Contact: Maria Teulon Gonzalez, MD PhD 916006252 email@example.com|
|Principal Investigator:||Patricia E Grant, MD||Boston Children's Hospital|
|Responsible Party:||Ellen Grant, Director, Fetal-Neonatal Neuroimaging and Developmental Science Center, Boston Children's Hospital|
|Other Study ID Numbers:||
R01EB017337-01 ( U.S. NIH Grant/Contract )
|First Posted:||November 21, 2014 Key Record Dates|
|Last Update Posted:||August 11, 2022|
|Last Verified:||August 2022|
Fetal Growth Retardation
Female Urogenital Diseases and Pregnancy Complications