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Currently there is no intervention to prevent persistent postpartum hypertension in preeclamptic women. Physiologically, the use of a pharmacokinetically predictable loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the incidence of persistent postpartum hypertension in preeclamptic women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Torsemide | Experimental | Torsemide 20 mg daily for 5 days |
|
| Placebo | Placebo Comparator | Placebo 20 mg daily for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Torsemide | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg | Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first. | 0-5 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg) | 0-6 weeks after delivery | |
| Number of Participants Requiring Postpartum Readmission | 0-6 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Torsemide Concentrations in Breast Milk | Ancillary study | 0-5 days after delivery |
| Electrolyte Profile in Maternal Serum | Concentrations of: Sodium, Potassium, Calcium |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30303905 | Derived | Viteri OA, Alrais MA, Pedroza C, Hutchinson M, Chauhan SP, Blackwell SC, Sibai BM. Torsemide for Prevention of Persistent Postpartum Hypertension in Women With Preeclampsia: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1185-1191. doi: 10.1097/AOG.0000000000002941. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Torsemide | Torsemide 20 mg daily for 5 days |
| FG001 | Placebo | Placebo 20 mg daily for 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Torsemide | Torsemide 20 mg daily for 5 days |
| BG001 | Placebo | Placebo 20 mg daily for 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg | Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first. | Intention-to-treat | Posted | Count of Participants | Participants | 0-5 days after delivery |
|
6 weeks
Only related adverse events were recorded. Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group, thus only 22 in the torsemide group and 31 in the placebo group are indicated as at risk for hypokalemia.
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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 | Torsemide | Torsemide 20 mg daily for 5 days | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia (low blood potassium levels) | General disorders | Systematic Assessment |
Median hospital stay <3 days, but sample size powered to detect differences in up to 5 days. High rate of clinic no-shows. Not powered to detect differences in secondary outcomes. Edema measurements done with stocking, which may affect reliability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oscar Andres Viteri Molina, MD | The University of Texas Health Science Center at Houston | (713) 500-6412 | Oscar.A.ViteriMolina@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 | Jun 23, 2016 | Jul 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
|
| Length of Hospital Stay After Delivery | 0-5 days after delivery |
| Weight Change | at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery) |
| Change in Lower Extremity Edema | Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus. | at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery) |
| Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) | 7-10 days after delivery |
| Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) | 6 weeks after delivery |
| Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels) | 0-5 days after delivery |
| Number of Participants With Side Effects of Therapy - Decreased Breast Milk | 0-5 days after delivery |
| Number of Participants With Severe Composite Maternal Morbidity | Severe composite maternal morbidity is defined as having any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy, or maternal death. | 0-6 weeks after delivery |
| 0-5 days after delivery |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) at delivery | Mean | Standard Deviation | kg/m^2 |
|
| Married | Count of Participants | Participants |
|
| Nulliparous | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Use of illicit drugs | Count of Participants | Participants |
|
| Use of Cocaine | Count of Participants | Participants |
|
| Prenatal care | Count of Participants | Participants |
|
| Form of Payment | Count of Participants | Participants |
|
| Pregestational Diabetes | Count of Participants | Participants |
|
| Gestational Diabetes | Count of Participants | Participants |
|
| Chronic Hypertension | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg) | Intention-to-treat | Posted | Count of Participants | Participants | 0-6 weeks after delivery |
|
|
|
|
| Secondary | Number of Participants Requiring Postpartum Readmission | Intention-to-treat | Posted | Count of Participants | Participants | 0-6 weeks after delivery |
|
|
|
|
| Secondary | Length of Hospital Stay After Delivery | Intention-to-treat | Posted | Median | Inter-Quartile Range | hours | 0-5 days after delivery |
|
|
|
|
| Secondary | Weight Change | Intention-to-treat | Posted | Mean | Standard Deviation | pounds | at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery) |
|
|
|
| Secondary | Change in Lower Extremity Edema | Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus. | Intention-to-treat | Posted | Mean | Standard Deviation | millimeters | at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery) |
|
|
|
| Secondary | Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) | 38 (42%) women in the torsemide group and 31 (53%) women in the placebo missed their outpatient clinic visit at 7-10 days after delivery, resulting in only 21 in the torsemide group and 28 in the placebo group being analyzed. | Posted | Count of Participants | Participants | 7-10 days after delivery |
|
|
|
|
| Secondary | Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) | 36 women in the torsemide group and 28 women in the placebo group did not show to their clinic appointment 6 weeks after delivery, resulting in 23 in the torsemide group and 31 in the placebo group being analyzed. | Posted | Count of Participants | Participants | 6 weeks after delivery |
|
|
|
|
| Secondary | Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels) | Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group. | Posted | Count of Participants | Participants | 0-5 days after delivery |
|
|
|
|
| Secondary | Number of Participants With Side Effects of Therapy - Decreased Breast Milk | Intention-to-treat | Posted | Count of Participants | Participants | 0-5 days after delivery |
|
|
|
| Secondary | Number of Participants With Severe Composite Maternal Morbidity | Severe composite maternal morbidity is defined as having any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy, or maternal death. | Intention-to-treat | Posted | Count of Participants | Participants | 0-6 weeks after delivery |
|
|
|
| Other Pre-specified | Torsemide Concentrations in Breast Milk | Ancillary study | Not Posted | 0-5 days after delivery | Participants |
| Other Pre-specified | Electrolyte Profile in Maternal Serum | Concentrations of: Sodium, Potassium, Calcium | Not Posted | 0-5 days after delivery | Participants |
| 59 |
| 0 |
| 59 |
| 2 |
| 59 |
| EG001 | Placebo | Placebo 20 mg daily for 5 days | 0 | 59 | 0 | 59 | 4 | 59 |
| Decreased breast milk | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |