Fetal Growth Restriction, Preeclampsia Severe
Conditions
Brief summary
This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.
Interventions
GENETICPlacental biopsy
Post-delivery placental sampling
GENETICUmbilical cord blood
Post-delivery umbilical cord blood sampling
GENETICExpanded panel cell free DNA testing (non-invasive prenatal testing)
Maternal blood sampling
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Inclusion criteria
* Diagnosis of early onset (\< 34 weeks) severe fetal growth restriction, defined as estimated fetal weight less than 10th percentile with abnormal umbilical artery Dopplers OR estimated fetal weight less than 5th percentile alone OR biometric size at least 14 days behind expected dates
Exclusion criteria
* Maternal age \< 18 years * Multifetal gestation * Chronic hypertension require use of pharmacotherapy * Tobacco or drug use * Major congenital malformations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite adverse pregnancy outcome | Through study completion, an average of 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth < 34 weeks | Through study completion, an average of 2 years | — |
| Neonatal intensive care unit admission | Through study completion, an average of 2 years | — |
| Intrauterine fetal demise | Through study completion, an average of 2 years | Death of fetus prior to delivery |
| Neonatal demise | Through study completion, an average of 2 years | Death of infant within 28 days of birth |
Countries
United States
Outcome results
None listed