The purpose of this study is to evaluate the efficacy of intravenous KW-3357 in patients with early-onset severe preeclampsia by comparing the prolongation days of pregnancy with that of placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
181
Intravenous infusion, once a day, 7 days
Intravenous infusion, once a day, 7 days
Days of maintaining pregnancy
Time frame: Subjects will be observed until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until approximately 34 0/7 weeks of gestation.
Presence or absence of achievement of 32 weeks of gestation
Time frame: 28 days before the end of study
Presence or absence of achievement of 34 weeks of gestation
Time frame: 28 days before the end of study
Presence or absence of achievement of 28 weeks of gestation in subjects enrolled in the period of less than 28 weeks of gestation
Time frame: 28 days before the end of study
Change in AT activity
Time frame: From baseline to Day 8 at all time points and 3 days after termination of pregnancy
Change in PLT concentration
Time frame: From baseline to Day 8 at all time points and 3 days after termination of pregnancy
Change on D-dimer concentration
Time frame: From baseline to Day 8 at all time points
Change in FDP concentration
Time frame: From baseline to Day 8 at all time points
Sitting systolic blood pressure and sitting diastolic blood pressure
Time frame: From baseline to Day 8 at each time point, 3 days after termination of pregnancy, and 28 days after termination of pregnancy
Proteinuria/creatinine ratio
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Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Toyota Memorial Hospital
Toyota, Aichi-ken, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo, Chiba, Japan
Ehime University Hospital
Tōon, Ehime, Japan
National Hospital Organization Kokura Medical Center
Kitakyushu, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
Kurume, Fukuoka, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, Japan
...and 53 more locations
Time frame: From baseline to Day 8 at each time point, 3 days after termination of pregnancy, and 28 days after termination of pregnancy
Amount of blood lost during delivery
Time frame: 28 days before the end of study
Biophysical Profile Score
Minimum is 0, max is 10. Higher score means better condition.
Time frame: From baseline to Day 8 at each time point
Fetal growth rate
Time frame: 28 days before the end of study
Apgar score
Minimum is 0, max is 10. Higher score means better condition.
Time frame: At 1 minute and 5 minutes after birth
Presence or absence of neonatal asphyxia
Time frame: At 1 minute and 5 minutes after birth
Birth weight
Time frame: 28 days before the end of study
Neonatal growth
Fetal growth is classified into small for gestational age (SGA), appropriate for gestational age (AGA), and large for gestational age (LGA).
Time frame: 28 days before the end of study
Head and chest circumferences at birth
Time frame: 28 days before the end of study
Short-term prognosis of neonates (incidence of bronchopulmonary dysplasia, intraventricular hemorrhage, periventricular leukolame, retinopathy of prematurity, sepsis, necrotizing enteritis, death, etc)
Time frame: 28 days after termination of pregnancy
The number of neonates who was hospitalized in the NICU
Time frame: 28 days after termination of pregnancy
The number of days in the NICU
Time frame: 28 days after termination of pregnancy
The number of neonates with respiratory management at the time of admission to the NICU
Time frame: 28 days after termination of pregnancy
The number of days of respiratory management at the time of admission to the NICU
Time frame: 28 days after termination of pregnancy