MedPath

MRI Assessment of Placental Health

Recruiting
Conditions
Intrauterine Growth Restriction
Registration Number
NCT02297724
Lead Sponsor
Boston Children's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> 1. The pregnant mother with twin gestation with diagnosis of selective IUGR based upon<br> obstetrical US findings as following:<br><br> - Proven monochorionicity / dichorionicity<br><br> - Discordance in estimated fetal weight (EFW). Growth restriction (<10 percentile<br> of norm) in one or both fetus(es) AND/OR growth discordance (> or = 20%)<br> between twin fetuses.<br><br> 2. The pregnant mother with singleton gestation with diagnosis of IUGR based upon<br> obstetrical US findings as following:<br><br> - Proven singleton gestation<br><br> - Growth restriction of fetus (<10 percentile of norm)<br><br> - Doppler measurements that indicates placental insufficiency: umbilical artery,<br> middle cerebral artery, uterine artery; or oligohydramnios.<br><br> 3. Gestational age: Bigger than 18 weeks.<br><br> 4. Pregnant mother is between age 18 to 45, clinically stable and can safely tolerate<br> fetal MRI study.<br><br>Exclusion Criteria:<br><br>Fetuses/infants with the following features will be excluded.<br><br> 1. Fetus/infant with chromosomal anomalies or known genetic disorders.<br><br> 2. Fetus/infant with other major congenital malformation.<br><br> 3. Presence of any condition or abnormality that in the opinion of the Investigator<br> would compromise the safety of the patient, quality or completeness of the data.<br><br>Pregnant mothers with the following features will be excluded.<br><br> 1. Mothers with contraindication to MRI (with pacemaker, metal in body, oversize).<br><br> 2. Mothers with claustrophobia<br><br> 3. Mothers medically unstable for the MRI study

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
BOLD MRI signal change during maternal oxygen exposure in placenta and fetus;placental volume on MRI image
Secondary Outcome Measures
NameTimeMethod
pathological reports of placenta after delivery;fetal growth curve after birth
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