Trial Outcomes & Findings for ToRsemide for pOstpartum HYpertension (NCT NCT02813551)
NCT ID: NCT02813551
Last Updated: 2019-04-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
0-5 days after delivery
Results posted on
2019-04-10
Participant Flow
Participant milestones
| Measure |
Torsemide
Torsemide 20 mg daily for 5 days
|
Placebo
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
58
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ToRsemide for pOstpartum HYpertension
Baseline characteristics by cohort
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 6.1 • n=93 Participants
|
28.2 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
27.6 years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
33 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Body Mass Index (BMI) at delivery
|
38.3 kg/m^2
STANDARD_DEVIATION 10.4 • n=93 Participants
|
37.0 kg/m^2
STANDARD_DEVIATION 9.9 • n=4 Participants
|
37.7 kg/m^2
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Married
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Nulliparous
|
38 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Smoker
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Use of illicit drugs
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Use of Cocaine
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Prenatal care
|
59 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Form of Payment
Government/Subsidized Insurance
|
46 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Form of Payment
Private Insurance
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Form of Payment
None/Self Paid
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Pregestational Diabetes
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Gestational Diabetes
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Chronic Hypertension
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Asthma
|
4 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 0-5 days after deliveryPopulation: Intention-to-treat
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.
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
|
26 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 0-6 weeks after deliveryPopulation: Intention-to-treat
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0-6 weeks after deliveryPopulation: Intention-to-treat
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants Requiring Postpartum Readmission
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0-5 days after deliveryPopulation: Intention-to-treat
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Length of Hospital Stay After Delivery
|
68 hours
Interval 52.0 to 94.0
|
54 hours
Interval 47.0 to 77.0
|
SECONDARY outcome
Timeframe: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)Population: Intention-to-treat
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Weight Change
|
3.01 pounds
Standard Deviation 3.85
|
2.08 pounds
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)Population: Intention-to-treat
Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Change in Lower Extremity Edema
|
-1.29 millimeters
Standard Deviation 12.08
|
-2.9 millimeters
Standard Deviation 14.08
|
SECONDARY outcome
Timeframe: 7-10 days after deliveryPopulation: 38 (42%) women in the torsemide group and 31 (53%) women in the placebo missed their outpatient clinic visit at 7-10 days after delivery, resulting in only 21 in the torsemide group and 28 in the placebo group being analyzed.
Outcome measures
| Measure |
Torsemide
n=21 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=28 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 weeks after deliveryPopulation: 36 women in the torsemide group and 28 women in the placebo group did not show to their clinic appointment 6 weeks after delivery, resulting in 23 in the torsemide group and 31 in the placebo group being analyzed.
Outcome measures
| Measure |
Torsemide
n=23 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=31 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 0-5 days after deliveryPopulation: Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group.
Outcome measures
| Measure |
Torsemide
n=22 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=31 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0-5 days after deliveryPopulation: Intention-to-treat
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants With Side Effects of Therapy - Decreased Breast Milk
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-6 weeks after deliveryPopulation: Intention-to-treat
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.
Outcome measures
| Measure |
Torsemide
n=59 Participants
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 Participants
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Number of Participants With Severe Composite Maternal Morbidity
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-5 days after deliveryAncillary study
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-5 days after deliveryConcentrations of: Sodium, Potassium, Calcium
Outcome measures
Outcome data not reported
Adverse Events
Torsemide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Torsemide
n=59 participants at risk
Torsemide 20 mg daily for 5 days
|
Placebo
n=59 participants at risk
Placebo 20 mg daily for 5 days
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Decreased breast milk
|
1.7%
1/59 • Number of events 1 • 6 weeks
Only related adverse events were recorded. Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group, thus only 22 in the torsemide group and 31 in the placebo group are indicated as at risk for hypokalemia.
|
0.00%
0/59 • 6 weeks
Only related adverse events were recorded. Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group, thus only 22 in the torsemide group and 31 in the placebo group are indicated as at risk for hypokalemia.
|
|
General disorders
Hypokalemia (low blood potassium levels)
|
4.5%
1/22 • Number of events 1 • 6 weeks
Only related adverse events were recorded. Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group, thus only 22 in the torsemide group and 31 in the placebo group are indicated as at risk for hypokalemia.
|
12.9%
4/31 • Number of events 4 • 6 weeks
Only related adverse events were recorded. Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group, thus only 22 in the torsemide group and 31 in the placebo group are indicated as at risk for hypokalemia.
|
Additional Information
Oscar Andres Viteri Molina, MD
The University of Texas Health Science Center at Houston
Phone: (713) 500-6412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place