Study of Pravastatin for Prevention of HDP

JRCT ID: jRCTs031230067

Registered date:11/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertensive disordrs of Pregnancy
• Date of first enrollment: 13/07/2023
• Target sample size: 90
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• 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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Female

Include 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

Exclude criteria

(1) Those diagnosed with antiphospholipid antibody syndrome
(2) Those with chronic hypertension in pregnancy
(3) Those with multiple pregnancies
(4) Those with severe obesity with a BMI of 30 or higher at the time of informed consent
(5) Those with a history of allergy to aspirin, salicylates, or pravastatin
(6) Those who have a history of serious drug allergy such as anaphylactic shock or a history of serious side effects
(7) Those who have participated in clinical research within 17 weeks before obtaining consent and have taken the study drug
(8) Those with serious hepatic disorder or a history of such disorder
(9) Those who are alcoholic
(10) Those with chronic kidney disease with CKD stage 4 or higher (eGFR<29)
(11) Those receiving fibrates, immunosuppressants, or nicotinic acid
(12) Those with untreated hypothyroidism (excluding subclinical hypothyroidism),
(13) Those with hereditary myopathy or family history of hereditary myopathy
(14) Those with history of drug-induced myopathy
(15) Those with peptic ulcer
(16) Those with bleeding tendency (except due to side effects of aspirin)
(17) Those with aspirin asthma or a history of aspirin asthma
(18) Those deemed by the principal investigator or co-investigator to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Kumasawa Keiichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development