Clinical trial NCT05016440: Lisinopril for Renal Protection in Postpartum Preeclamptic Women
Official title: Lisinopril To Reduce Microalbuminuria In Postpartum Preeclamptic Women. A Role For Renal Protection?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Microalbuminuria
Preeclampsia
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There may be a role for Lisinopril in improving renal protection in post-partum women who had preeclampsia during pregnancy. The aim of this study is to determine whether routine initiation of Lisinopril after delivery, in women who had preeclampsia while they were pregnant, can control high blood pressure and improve kidney function.

Detailed description: This study is being done to determine the effects (good or bad) of Lisinopril (high blood pressure medication) in controlling high blood pressure and improving kidney function for women after delivery who had preeclampsia while they were pregnant .Preeclampsia is a condition that can occur during pregnancy, up to 6 weeks post partum, where the mother's blood pressure is high and protein is present in the urine. This can be dangerous for both the mother and fetus. Although the blood pressure usually returns to normal after delivery, elevated pressures may continue. Normally medication is given when you continue to have high blood pressure after delivery. High blood pressure can cause damage to the kidneys. Lisinopril is a medication that can be used to treat high blood pressure after delivery. Lisinopril offers kidney protection in patients diagnosed with diabetes. We currently do not know if lisinopril can offer the same kidney protection in women diagnosed with preeclampsia. Considering that 10% of all pregnant women develop preeclampsia, the number of women who may eventually develop end stage kidney disease is relatively large and any relatively safe and easy means to prevent this disease would be beneficial.

Eligibility criteria: Inclusion Criteria:

* Women 18 to 50 yrs of age with mild or severe preeclampsia diagnosed using criteria (listed below) set forth by the American College of Obstetrics and Gynecology (ACOG) Criteria. (Note; women who become eclamptic will be included in the study.)

  * Blood Pressure of 140 mmHg systolic or greater or 90 mmHg diastolic or higher that occurs after 20 weeks' gestational age in a woman with previously normal blood pressure
  * Proteinuria defined as 0.3 g protein or higher in a 24 hour urine specimen.
  * Preeclampsia was considered severe when any of the following were present:

    1. Blood pressure of 160 mmHg systolic of higher or 110 mg Hg diastolic or higher on two occasions at least 6 hours apart while the patient is on bed rest
    2. Proteinuria of 5 grams of higher in a 24-hour urine specimen of 3+ or greater on two random urine samples collected at least 4 hours apart
    3. Oliguria of less than 500cc in 24 hours
    4. Cerebral of visual disturbances
    5. Pulmonary edema or cyanosis
    6. Epigastric or right upper quadrant pain
    7. Impaired liver function, thrombocytopenia
    8. Fetal growth restriction.

Exclusion Criteria:

* Women with:

  * Prior hypersensitivity (allergic reaction) to Lisinopril or ACE Inhibitors
  * Pre-gestational chronic hypertension
  * Pre-gestational diabetes
  * Rheumatologic disorders (i.e., systemic lupus erythematosus, scleroderma)
  * Multiple gestations for present pregnancy
  * Patients who declined birth control postpartum
  * Patient who has been on an Ace-inhibitor within 6 months prior to pregnancy
  * Cardiac problems like; Aortic stenosis or Hypertrophic cardiomyopathy
  * Severe kidney disease
  * Myocardial infarction within the past 6 months
  * Taking any of the prohibited medications listed in section VI
  * Breast feeding
  * Prisoners will not be included in the study due to difficulty in tracking their pregnancy care being provided at the prison centers

Primary outcomes:
measure: Albumin Excretion Rate in mg/mmol
timeFrame: Change is being assessed within 24 hours of delivery and 6-8 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: James Hill, MD
role: PRINCIPAL_INVESTIGATOR
References: