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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hctz/Lisinopril | Experimental | Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) |
|
| Extended release nifedipine | Active Comparator | calcium channel blocker (Nifedipine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE Inhibitors and Diuretics | Drug | Hctz/Lisinopril (brand name: Zestoretic) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stage 2 Hypertension | 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. | 7-10 after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe Postpartum Hypertension | severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart) | 7-10 after delivery |
| Number of Participants Who Received Additional Antihypertensive During Admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Fishel Bartal, MD | UT Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hctz/Lisinopril | Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic) |
| FG001 | Extended release nifedipine | calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hctz/Lisinopril | Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic) |
| BG001 | Extended release nifedipine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Stage 2 Hypertension | 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. | Data were not collected for 1 participants in the Hctz/Lisionpril arm. Data were not collected for 8 participants in the extended release nifedipine arm. | Posted | Count of Participants | Participants | 7-10 after delivery |
|
Up to 6 weeks post delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hctz/Lisinopril | Hctz/Lisinopril for postpartum management of hypertension. either a combined pill of ACE inhibitors and diuretics (Hydrochlorothiazide/Lisinopril) ACE Inhibitors and Diuretics: Hctz/Lisinopril (brand name: Zestoretic) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intensive care unit admission | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michal Fishel Bartal, MD | The University of Texas Health Science Center at Houston | (713) 500-6421 | michal.f.bartal@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2022 | Jun 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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randomized control trial
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| NIFEdipine ER |
| Drug |
Extended release nifedipine |
|
number of participants who received additional antihypertensive during admission, at 7-10 days postpartum. |
| 7-10 days postpartum |
| Postpartum Length of Stay | time spent in hospital following delivery | up to 30 days after delivery |
| Postpartum Readmission | occurrence of returning to hospital for admission postpartum | up to 30 days after delivery |
| Time to Blood Pressure Control | The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100). | 10 days |
| Incidence of Persistent Postpartum Hypertension | Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg). | 6 weeks postpartum |
| Occurrence of Proteinuria | Proteinuria is measured by urine protein creatinine ratio | 7-10 days, and 6 weeks postpartum |
| Presense of Labs Abnormality | Labs abnormality including hyperkalemia or creatinine increase | 7-10 days, and 6 weeks postpartum |
| Compliance With Medications | 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. | at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth |
| Time to Control Blood Pressure | 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 | 3 month-1 year |
| Number of Patients Receiving Primary Care With BP Measurement | Number of patients receiving primary care with BP measurement at 1 year | 1 year postpartum |
| Postpartum Complications- Number of Participants With ICU Admission | Need for ICU admission | 10 days postpartum |
| Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome | Hemolysis, elevated liver enzymes, low platelet count: HELLP | 10 days postpartum |
| Postpartum Complications- Number of Participants With Eclampsia | 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. | 10 days postpartum |
| Postpartum Complications- Number of Participants With Stroke | Stroke | 10 days postpartum |
| Postpartum Complications- Number of Participants With Renal Failure | Renal failure | 10 days postpartum |
| Postpartum Complications- Number of Participants With Pulmonary Edema | Pulmonary edema | 10 days postpartum |
| Postpartum Complications - Number of Participants With Cardiomyopathy | Cardiomyopathy | 10 days postpartum |
| Postpartum Complications- Number of Participants With Maternal Death | Maternal death | 10 days postpartum |
| Receipt of Additional Antihypertensive During Admission | Receipt of additional antihypertensive during admission at 6 weeks postpartum | 6 weeks postpartum |
calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of participants with private insurance for prenatal care | Count of Participants | Participants |
|
| Number of participants that are Married/living with partner | Count of Participants | Participants |
|
| Number of participants with Nulliparous | Count of Participants | Participants |
|
| Pre-pregnancy Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Number of participants with a BMI ≥ 30 | Count of Participants | Participants |
|
| Number of participants with Diabetes diagnosed prior to pregnancy | Count of Participants | Participants |
|
| Number of participants with Gestational diabetes | Count of Participants | Participants |
|
| Number of participants with Thyroid disease | Count of Participants | Participants |
|
| Number of participants who Smoke during pregnancy | Count of Participants | Participants |
|
| Number of participants with Alcohol use during pregnancy | Count of Participants | Participants |
|
| Number of participants with Substance use during pregnancy | Count of Participants | Participants |
|
| Number of participants with Chronic hypertension | Count of Participants | Participants |
|
| Number of participants who Use Blood Pressure medication during pregnancy | Count of Participants | Participants |
|
| Number of participants with Hypertensive disorder during pregnancy | Hypertensive disorder including gestational hypertension, preeclampsia, or superimposed preeclampsia. | Count of Participants | Participants |
|
| Number of participants with Preeclampsia with severe features | Count of Participants | Participants |
|
| Number of participants with New onset postpartum hypertension | Count of Participants | Participants |
|
| Number of participants who had labor induced | Count of Participants | Participants |
|
| Gestational weeks at delivery | Median | Inter-Quartile Range | weeks |
|
| Number of pre-term delivery | Count of Participants | Participants |
|
| Number of Cesarean delivery | Count of Participants | Participants |
|
| Number of participants who Need IV Blood Pressure medications prior to randomization | Count of Participants | Participants |
|
| Postpartum day at randomization | Median | Inter-Quartile Range | days |
|
| Extended release nifedipine |
calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine |
|
|
| Secondary | Number of Participants With Severe Postpartum Hypertension | severe postpartum hypertension (SBP≥160 and/or DBP≥110 mmHg on 2 occasions, 15 minutes apart) | Posted | Count of Participants | Participants | 7-10 after delivery |
|
|
|
| Secondary | Number of Participants Who Received Additional Antihypertensive During Admission | number of participants who received additional antihypertensive during admission, at 7-10 days postpartum. | Posted | Count of Participants | Participants | 7-10 days postpartum |
|
|
|
| Secondary | Postpartum Length of Stay | time spent in hospital following delivery | Posted | Median | Inter-Quartile Range | days | up to 30 days after delivery |
|
|
|
| Secondary | Postpartum Readmission | occurrence of returning to hospital for admission postpartum | Posted | Count of Participants | Participants | up to 30 days after delivery |
|
|
|
| Secondary | Time to Blood Pressure Control | The time from delivery to Blood Pressure control (i.e time from delivery to last BP <150/100). | Data were not collected for this outcome measure. | Posted | 10 days |
|
|
| Secondary | Incidence of Persistent Postpartum Hypertension | Incidence of persistent postpartum hypertension 6 weeks postpartum (SBP ≥ 140 and/or DBP ≥ 90 mmHg). | Data were not collected for this outcome measure. | Posted | 6 weeks postpartum |
|
|
| Secondary | Occurrence of Proteinuria | Proteinuria is measured by urine protein creatinine ratio | Data were not collected for this outcome measure | Posted | 7-10 days, and 6 weeks postpartum |
|
|
| Secondary | Presense of Labs Abnormality | Labs abnormality including hyperkalemia or creatinine increase | Data were not collected for this outcome measure | Posted | 7-10 days, and 6 weeks postpartum |
|
|
| Secondary | Compliance With Medications | 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. | Data were not collected for 4 participants in the Hctz/Lisinopril arm. Data were not collected for 8 participants in the Extended release nifedipine arm | Posted | Count of Participants | Participants | at the time of the 1st postpartum clinic visit, which is about 6 to 37 days after birth |
|
|
|
| Secondary | Time to Control Blood Pressure | 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 | Data were not collected for this outcome measure. | Posted | 3 month-1 year |
|
|
| Secondary | Number of Patients Receiving Primary Care With BP Measurement | Number of patients receiving primary care with BP measurement at 1 year | Data were not collected for this outcome because participants were lost to follow up. | Posted | 1 year postpartum |
|
|
| Secondary | Postpartum Complications- Number of Participants With ICU Admission | Need for ICU admission | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Postpartum Complications- Number of Participants With HELLP (Hemolysis, Elevated Liver Enzymes and Low Platelets) Syndrome | Hemolysis, elevated liver enzymes, low platelet count: HELLP | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Postpartum Complications- Number of Participants With Eclampsia | 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. | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Postpartum Complications- Number of Participants With Stroke | Stroke | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Postpartum Complications- Number of Participants With Renal Failure | Renal failure | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Postpartum Complications- Number of Participants With Pulmonary Edema | Pulmonary edema | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Postpartum Complications - Number of Participants With Cardiomyopathy | Cardiomyopathy | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Postpartum Complications- Number of Participants With Maternal Death | Maternal death | Posted | Count of Participants | Participants | 10 days postpartum |
|
|
|
| Secondary | Receipt of Additional Antihypertensive During Admission | Receipt of additional antihypertensive during admission at 6 weeks postpartum | Data were not collected for this outcome measure | Posted | 6 weeks postpartum |
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| 0 |
| 34 |
| EG001 | Extended release nifedipine | calcium channel blocker (Nifedipine NIFEdipine ER: Extended release nifedipine | 0 | 36 | 0 | 36 | 0 | 36 |
| HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020164 | Chemical Actions and Uses |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |