ToRsemide for pOstpartum HYpertension

Phase 2

Completed

• Conditions: Preeclampsia
• Interventions: Drug: Placebo; Drug: Torsemide

• Registration Number: NCT02813551
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-19
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Study Start: 2016-08
• Primary Completion: 2017-07-28
• Study Completion: 2017-09-09
• Results First Submitted: 2018-07-27
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-21
• Last Update Submitted: 2019-03-21
• Results First Posted: 2019-04-10
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 20 mg daily for 5 days
Torsemide	Torsemide	Torsemide 20 mg daily for 5 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg	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

Name	Time	Method
Weight Change	at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
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
Length of Hospital Stay After Delivery	0-5 days after delivery
Change in Lower Extremity Edema	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.
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	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States