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Trial record 23 of 31 for:    "Preeclampsia/eclampsia 1" | "Antihypertensive Agents"

ToRsemide for pOstpartum HYpertension (TROPHY)

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ClinicalTrials.gov Identifier: NCT02813551
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Oscar Andres Viteri Molina, The University of Texas Health Science Center, Houston

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Torsemide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial
Study Start Date : August 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : September 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
Drug Information available for: Torsemide

Arm Intervention/treatment
Experimental: Torsemide
Torsemide 20 mg daily for 5 days
Drug: Torsemide
Other Name: Demadex, torasemide

Placebo Comparator: Placebo
Placebo 20 mg daily for 5 days
Drug: Placebo



Primary Outcome Measures :
  1. Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg [ Time Frame: 0-5 days after delivery ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg) [ Time Frame: 0-6 weeks after delivery ]
  2. Number of Participants Requiring Postpartum Readmission [ Time Frame: 0-6 weeks after delivery ]
  3. Length of Hospital Stay After Delivery [ Time Frame: 0-5 days after delivery ]
  4. Weight Change [ Time Frame: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery) ]
  5. Change in Lower Extremity Edema [ Time Frame: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery) ]
    Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.

  6. Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) [ Time Frame: 7-10 days after delivery ]
  7. Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) [ Time Frame: 6 weeks after delivery ]
  8. Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels) [ Time Frame: 0-5 days after delivery ]
  9. Number of Participants With Side Effects of Therapy - Decreased Breast Milk [ Time Frame: 0-5 days after delivery ]
  10. Number of Participants With Severe Composite Maternal Morbidity [ Time Frame: 0-6 weeks after delivery ]
    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.


Other Outcome Measures:
  1. Torsemide Concentrations in Breast Milk [ Time Frame: 0-5 days after delivery ]
    Ancillary study

  2. Electrolyte Profile in Maternal Serum [ Time Frame: 0-5 days after delivery ]
    Concentrations of: Sodium, Potassium, Calcium



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postpartum women at ≥ 18 years of age
  • Antepartum/intrapartum or within 24 hours postpartum diagnosis of either:
  • Preeclampsia
  • Preeclampsia with severe features
  • Preeclampsia superimposed to chronic hypertension

Exclusion Criteria:

  • Chronic hypertension without superimposed preeclampsia
  • Gestational hypertension
  • Urine output < 30 cc/h at time of randomization
  • Heart failure or pulmonary edema
  • Hypersensitivity to Torsemide or sulfonylureas
  • Hypokalemia (serum potassium < 3 mEq/L)
  • Preexisting diuretic use within 24 hours prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813551


Locations
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United States, Texas
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Oscar Andres Viteri Molina, The University of Texas Health Science Center, Houston:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oscar Andres Viteri Molina, Maternal-Fetal Medicine Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02813551     History of Changes
Other Study ID Numbers: HSC-MS-16-0198
First Posted: June 27, 2016    Key Record Dates
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Oscar Andres Viteri Molina, The University of Texas Health Science Center, Houston:
Preeclampsia, puerperium
Additional relevant MeSH terms:
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Pre-Eclampsia
Antihypertensive Agents
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Torsemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action