Lisinopril for Renal Protection in Postpartum Preeclamptic Women

NCT05016440 | Withdrawn DMC

• 1 other identifier: Lisinopril-Renal Protection
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Microalbuminuria; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Albumin Excretion Rate in mg/mmol

  Prior to discharge from the hospital, either during the woman's labor progress or immediately post delivery, a catheterized urine specimen will be obtained and sent to the lab for an Albumin-Creatinine Ratio (ACR) by a nurse. Following discharge, the woman will be seen 6-8 weeks postpartum for her routine postpartum visit. If the woman reports vaginal spotting or bleeding a straight catheter urine specimen will be obtained, otherwise a clean catch specimen may be obtained, and sent for lab assessment of Albumin-Creatinine Ratio (ACR). This collection of a urine specimen is standard of care for our pregnant and postpartum patients. Prior to hospital discharge, she will also be instructed to collect a 24 hour urine specimen collection, the day before her 6-8 week postpartum visit and bring it with her to this visit. When analyzed, this second 24 hour urine specimen will be assessed for both albumin concentration and albumin/creatinine ratio (Albumin Excretion Rate).

  Change is being assessed within 24 hours of delivery and 6-8 weeks postpartum

Study Arms (2)

Lisinopril

ACTIVE COMPARATOR

10mg Lisinopril tablets

Drug: Lisinopril

Sugar pill

PLACEBO COMPARATOR

sugar pill

Drug: Lisinopril

Interventions

Lisinopril DRUG

10mg Lisinopril daily for 6-8 weeks postpartum

Lisinopril; Sugar pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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
• 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
• Oliguria of less than 500cc in 24 hours
• Cerebral of visual disturbances
• Pulmonary edema or cyanosis
• Epigastric or right upper quadrant pain
• Impaired liver function, thrombocytopenia
• Fetal growth restriction.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• James Hill, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 23, 2021
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

US (1)