Back to resultsLisinopril for Renal Protection in Postpartum Preeclamptic Women
Primary Purpose
Microalbuminuria, Preeclampsia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lisinopril
Sponsored by
About this trial
This is an interventional treatment trial for Microalbuminuria
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:
- 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.
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
Sites / Locations
- Eastern Virginia Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lisinopril
Sugar pill
Arm Description
10mg Lisinopril tablets
sugar pill
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05016440
First Posted
August 20, 2014
Last Updated
August 16, 2021
Sponsor
Eastern Virginia Medical School
1. Study Identification
Unique Protocol Identification Number
NCT05016440
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Study Start Date
September 2015 (Anticipated)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
September 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Virginia Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microalbuminuria, Preeclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lisinopril
Arm Type
Active Comparator
Arm Description
10mg Lisinopril tablets
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Intervention Description
10mg Lisinopril daily for 6-8 weeks postpartum
Primary Outcome Measure Information:
Title
Albumin Excretion Rate in mg/mmol
Description
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).
Time Frame
Change is being assessed within 24 hours of delivery and 6-8 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hill, MD
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lisinopril for Renal Protection in Postpartum Preeclamptic Women
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