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Completed

NCT Number: NCT02813551

ToRsemide for pOstpartum HYpertension

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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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Torsemide

Drug

Other names: Demadex, torasemide

Placebo

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial

Acronym: TROPHY

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2016
Registry last updated
Apr 10, 2019

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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