ToRsemide for pOstpartum HYpertension

Preeclampsia Clinical Trial

— TROPHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813551
• Other study ID #: HSC-MS-16-0198
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: September 9, 2017

Study information

• Verified date: March 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 9, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Torsemide

• Placebo

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Torsemide Concentrations in Breast Milk	Ancillary study	0-5 days after delivery
Other	Electrolyte Profile in Maternal Serum	Concentrations of: Sodium, Potassium, Calcium	0-5 days after delivery
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.	0-5 days after delivery
Secondary	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
Secondary	Number of Participants Requiring Postpartum Readmission		0-6 weeks after delivery
Secondary	Length of Hospital Stay After Delivery		0-5 days after delivery
Secondary	Weight Change		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.	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)		7-10 days after delivery
Secondary	Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure =140 and/or Diastolic Blood Pressure = 90 mmHg)		6 weeks after delivery
Secondary	Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)		0-5 days after delivery
Secondary	Number of Participants With Side Effects of Therapy - Decreased Breast Milk		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.	0-6 weeks after delivery