The study will primarily evaluate safety of the KNP-1000 apheresis system for pregnant women and their fetuses diagnosed with preeclampsia with severe features between 23- and 32-weeks' gestation (very preterm).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
sFlt-1 is removed from the participants' plasma through treatment.
Antepartum maternal and fetal device-related serious adverse events
Rate of antepartum maternal and fetal device-related serious adverse events
Time frame: Until date of delivery
Postpartum maternal and neonatal device-related serious adverse events
Rate of postpartum maternal and neonatal device-related serious adverse events
Time frame: Following delivery until end of follow-up (2 years)
Maternal, fetal, and neonatal mortality
Rate of maternal, fetal, and neonatal mortality
Time frame: Until end of follow-up (2 years)
Obstetric complication
Incidence rate of obstetric complication
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Fetal complications
Incidence rate of fetal complications
Time frame: Until date of delivery
Neonatal morbidities associated with premature delivery
Incidence rate of neonatal morbidities associated with premature delivery
Time frame: Following delivery until discharge or 6 weeks after delivery, whichever occurs first
Neonatal intensive care unit (NICU) admissions
Rate of NICU admissions and length of stay
Time frame: From date of NICU admission until the date of NICU discharge, assessed up to 24 months
Prolongation of pregnancy
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Number of days from enrollment to delivery
Time frame: Until date of delivery
Maternal systolic blood pressure
Change in maternal systolic blood pressure over the duration of the investigation
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Maternal diastolic blood pressure
Change in maternal diastolic blood pressure over the duration of the investigation
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first
Maternal proteinuria
Change in maternal proteinuria before and after each procedure
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
Gestational age of the neonate at delivery
Gestational age of the neonate at delivery
Time frame: At date of delivery
Weight of neonate at delivery
Weight of neonate at delivery
Time frame: At date of delivery
Amniotic fluid volume
Change in amniotic fluid volume before and after each procedure
Time frame: Until the date of delivery, an average of 3 months
Fetal umbilical artery flow
Change in fetal umbilical artery flow before and after each procedure
Time frame: Until the date of delivery, an average of 3 months
Uterine artery flow
Change in uterine artery flow before and after each procedure
Time frame: Until the date of delivery, an average of 3 months
Maternal low-density lipoprotein cholesterol (LDL-C) levels
Change in LDL-C levels in maternal serum before and after each procedure
Time frame: Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months
Fetal growth restriction
Incidence rate of fetal growth restriction
Time frame: Until date of delivery
APGAR scores
Neonatal APGAR scores
Time frame: At date of delivery
Umbilical artery and vein blood gases
Umbilical artery and vein blood gases
Time frame: At date of delivery
Bayley Scales
Bayley Scales of Infant and Toddler Development, Fourth Edition assessment at 6, 12, and 24 months after delivery. Standard score (Composite score) range from 40 to 160, with higher scores indicating higher performance.
Time frame: At 6, 12, and 24 months after delivery
Body weight of infant
Body weight (grams) of infant at birth and during extended follow-up
Time frame: Following delivery until end of follow-up (2 years)
Body length and head circumference of infant
Body length and head circumference (centimeters) of infant at birth and during extended follow-up
Time frame: Following delivery until end of follow-up (2 years)