Study of Pravastatin for Prevention of HDP

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Aspirin and pravastatin will be used off‐label for the prevention of gestational hypertension. In addition, pregnant women with a history of previous gestational hypertension will be randomly assigned to groups A, B, and C as below. A aspirin 100mg/day B aspirin 100mg/day + pravastatin 5mg/day C aspirin 100mg/day + pravastatin 10mg/day Off label use of aspirin and pravastatin, randomized CONDITION: Hypertensive disordrs of Pregnancy ; pregnant woman, Recurrence prevention of Hypertensive disordrs of Pregnancy, HDP pregnant woman, Recurrence prevention of Hypertensive disordrs of Pregnancy, HDP PRIMARY OUTCOME: Incidence of hypertensive disorders of pregnancy SECONDARY OUTCOME: (1) Incidence of preeclampsia orgestational hypertension; (2) Maternal serum sFlt‐1/PlGF ratio; (3) Presence of maternal proteinuria; (4) Weight of placenta; (5) Lipid profile in cord blood; (6) Incidence of hypertensive disorders of pregnancy‐related complications (placental abruption, HELLP syndrome, eclampsia); (7) Weeks of pregnancy at the onset of hypertensive disorders of pregnancy; (8) Incidence of severe hypertensive disorders of pregnancy; (9) Neonatal information (birth weight, proportion of SGA infants, NICU admission rate, auditory brainstem response); (10) Adverse events (miscarriage, stillbirth) INCLUSION CRITERIA: (1) Those with a history of hypertensive disorders of pregnancy in previous pregnancies (2) Those between 13 weeks 0 days and 16 weeks 6 days of pregnancy at the time of informed consent (3) Age: Those who are between 18 and 45 years of age at the time of obtaining consent (4) Gender : Female (5) Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study (6) Those who can make outpatient visits in accordance with the research implementation schedule
Epistemonikos ID: ce74451daacecc56721407959bb94fb6a6ba61e5
First added on: Aug 26, 2024