Pre-Eclampsia, Severe
Conditions
Brief summary
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).
Interventions
DEVICEKNP-1000 Apheresis System
sFlt-1 is removed from the participants' plasma through treatment.
Sponsors
Kaneka Medical America LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
A participant is deemed suitable for inclusion in the investigation if she meets the following criteria: 1. Pregnant woman ≥ 23 0/7 and \< 32 0/7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment. 2. Severe hypertension ever defined by resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 110 mm Hg on two occasions measured at least 4 hours apart. 3. Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein/creatinine ratio. 4. Provision of signed and dated informed consent form.
Exclusion criteria
A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met. Maternal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antepartum maternal and fetal device-related serious adverse events | Until date of delivery | Rate of antepartum maternal and fetal device-related serious adverse events |
| Postpartum maternal and neonatal device-related serious adverse events | Following delivery until end of follow-up (2 years) | Rate of postpartum maternal and neonatal device-related serious adverse events |
| Maternal, fetal, and neonatal mortality | Until end of follow-up (2 years) | Rate of maternal, fetal, and neonatal mortality |
| Obstetric complication | Until discharge or 6 weeks after delivery, whichever occurs first | Incidence rate of obstetric complication |
| Fetal complications | Until date of delivery | Incidence rate of fetal complications |
| Neonatal morbidities associated with premature delivery | Following delivery until discharge or 6 weeks after delivery, whichever occurs first | Incidence rate of neonatal morbidities associated with premature delivery |
| Neonatal intensive care unit (NICU) admissions | From date of NICU admission until the date of NICU discharge, assessed up to 24 months | Rate of NICU admissions and length of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolongation of pregnancy | Until date of delivery | Number of days from enrollment to delivery |
| Maternal systolic blood pressure | Until discharge or 6 weeks after delivery, whichever occurs first | Change in maternal systolic blood pressure over the duration of the investigation |
| Maternal diastolic blood pressure | Until discharge or 6 weeks after delivery, whichever occurs first | Change in maternal diastolic blood pressure over the duration of the investigation |
| Maternal proteinuria | Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months | Change in maternal proteinuria before and after each procedure |
| Gestational age of the neonate at delivery | At date of delivery | Gestational age of the neonate at delivery |
| Weight of neonate at delivery | At date of delivery | Weight of neonate at delivery |
| Amniotic fluid volume | Until the date of delivery, an average of 3 months | Change in amniotic fluid volume before and after each procedure |
| Fetal umbilical artery flow | Until the date of delivery, an average of 3 months | Change in fetal umbilical artery flow before and after each procedure |
| Uterine artery flow | Until the date of delivery, an average of 3 months | Change in uterine artery flow before and after each procedure |
| Maternal low-density lipoprotein cholesterol (LDL-C) levels | Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months | Change in LDL-C levels in maternal serum before and after each procedure |
| Fetal growth restriction | Until date of delivery | Incidence rate of fetal growth restriction |
| APGAR scores | At date of delivery | Neonatal APGAR scores |
| Umbilical artery and vein blood gases | At date of delivery | Umbilical artery and vein blood gases |
| Bayley Scales | At 6, 12, and 24 months after delivery | 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. |
| Body weight of infant | Following delivery until end of follow-up (2 years) | Body weight (grams) of infant at birth and during extended follow-up |
| Body length and head circumference of infant | Following delivery until end of follow-up (2 years) | Body length and head circumference (centimeters) of infant at birth and during extended follow-up |
Contacts
CONTACTTakashi Shimai
Outcome results
None listed