University of Texas Health Science Center
Houston, Texas, 77030, United States
NCT Number: NCT05049616
The purpose of this study is to see if a combined pill of Angiotensin-converting enzyme (ACE) inhibitors (a medication that helps relax your veins and arteries to lower your blood pressure) with diuretics (sometimes called water pills, help rid your body of salt and water) will control blood pressure better than a different blood pressure medication of calcium channel blocker (lower your blood pressure by preventing calcium from entering the cells of your heart and arteries). Both medications are part of our usual care for high blood pressure after delivery.
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Notify Me18 year and older
Female
Interventional
Phase 4
Houston, Texas, 77030, United States
In individuals with preeclampsia, persistent hypertension and edema result in part from the mobilization of up to 8 liters of fluid and sodium from the extravascular to intravascular space. The increased urinary sodium excretion on days 3-5 postpartum likely results from higher atrial natriuretic peptide concentrations in plasma and activation of the renin-angiotensin-aldosterone system. Adding diuretics for postpartum hypertension has been associated with better blood pressure control in some of the studies.
Hypothesis: that in postpartum women with hypertensive disorders, oral combined Hydrochlorothiazide/Lisinopril will reduce postpartum hypertension at 7 days after delivery compared to usual care with calcium channel blockers.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hctz/Lisinopril (brand name: Zestoretic)
Extended release nifedipine
Time frame: 7-10 after delivery
Stage 2 hypertension at day 7-10 after delivery (defined as SBP ≥ 140 and/or DBP ≥ 90 mmHg) or admission to the hospital for blood pressure control prior to day 10.
Primary outcome will be calculated as the average BP reading for day 7-10 after delivery.
Time frame: 7-10 after delivery
severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart)
Time frame: 7-10 days postpartum
number of participants who received additional antihypertensive during admission, at 7-10 days postpartum.
Time frame: up to 30 days after delivery
time spent in hospital following delivery
Time frame: up to 30 days after delivery
occurrence of returning to hospital for admission postpartum
Time frame: 10 days
The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100).
Time frame: 6 weeks postpartum
Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg).
Time frame: 7-10 days, and 6 weeks postpartum
Proteinuria is measured by urine protein creatinine ratio
Time frame: 7-10 days, and 6 weeks postpartum
Labs abnormality including hyperkalemia or creatinine increase
Time frame: at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth
Compliance with medications. The patient will be asked to bring their medication bottle with them and the compliance will be measured by counting pills at each postpartum visit.
Time frame: 3 month-1 year
Blood pressure at 3 month, 6 month, 9 month, 1 year after delivery and need for BP medications. Definition of controlled blood pressure is (SBP < 140 and/or DBP < 90 mmHg). This will be assessed by telephone encounter with the patient
Time frame: 1 year postpartum
Number of patients receiving primary care with BP measurement at 1 year
Time frame: 10 days postpartum
Need for ICU admission
Time frame: 10 days postpartum
Hemolysis, elevated liver enzymes, low platelet count: HELLP
Time frame: 10 days postpartum
Eclampsia, which is considered a complication of severe preeclampsia, is commonly defined as new onset of grand mal seizure activity and/or unexplained coma during pregnancy or postpartum in a woman with signs or symptoms of preeclampsia.
Time frame: 10 days postpartum
Stroke
Time frame: 10 days postpartum
Renal failure
Time frame: 10 days postpartum
Pulmonary edema
Time frame: 10 days postpartum
Cardiomyopathy
Time frame: 10 days postpartum
Maternal death
Time frame: 6 weeks postpartum
Receipt of additional antihypertensive during admission at 6 weeks postpartum
The University of Texas Health Science Center, Houston
Other
Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension: A Comparative Effectiveness Pilot Randomized Controlled Trial
Acronym: ACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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