Lisinopril for Renal Protection in Postpartum Preeclamptic Women

August 16, 2021 updated by: Eastern Virginia Medical School

Lisinopril To Reduce Microalbuminuria In Postpartum Preeclamptic Women. A Role For Renal Protection?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lisinopril
10mg Lisinopril tablets
Drug: Lisinopril
10mg Lisinopril daily for 6-8 weeks postpartum
Placebo Comparator: Sugar pill
sugar pill
Drug: Lisinopril
10mg Lisinopril daily for 6-8 weeks postpartum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Albumin Excretion Rate in mg/mmol
Time Frame: Change is being assessed within 24 hours of delivery and 6-8 weeks postpartum
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eastern Virginia Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Hill, MD, Eastern Virginia Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Lisinopril-Renal Protection

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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