Clinical trial NCT02813551: ToRsemide for pOstpartum HYpertension
Official title: Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preeclampsia
Keywords: Preeclampsia, puerperium
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
timeFrame: 0-5 days after delivery
Secondary outcomes:
measure: Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)
timeFrame: 0-6 weeks after delivery
measure: Number of Participants Requiring Postpartum Readmission
timeFrame: 0-6 weeks after delivery
measure: Length of Hospital Stay After Delivery
timeFrame: 0-5 days after delivery
measure: Weight Change
timeFrame: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
measure: Change in Lower Extremity Edema
timeFrame: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
measure: Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
timeFrame: 7-10 days after delivery
measure: Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
timeFrame: 6 weeks after delivery
measure: Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)
timeFrame: 0-5 days after delivery
measure: Number of Participants With Side Effects of Therapy - Decreased Breast Milk
timeFrame: 0-5 days after delivery
measure: Number of Participants With Severe Composite Maternal Morbidity
timeFrame: 0-6 weeks after delivery
Other outcomes:
measure: Torsemide Concentrations in Breast Milk
timeFrame: 0-5 days after delivery
measure: Electrolyte Profile in Maternal Serum
timeFrame: 0-5 days after delivery
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
References:
citation: 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.