Trial Outcomes & Findings for Postpartum Management of Gestational Hypertensive Disorders Using Furosemide (NCT NCT04343235)
NCT ID: NCT04343235
Last Updated: 2023-10-23
Results Overview
number of patients who require a change in the dose of labetalol to control BP
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
Labetalol + Furosemide
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Labetalol + Furosemide
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Postpartum Management of Gestational Hypertensive Disorders Using Furosemide
Baseline characteristics by cohort
| Measure |
Labetalol + Furosemide
n=6 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=7 Participants
labetalol only
labetalol: 200mg labetalol BID
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
27.5 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)number of patients who require a change in the dose of labetalol to control BP
Outcome measures
| Measure |
Labetalol + Furosemide
n=6 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=7 Participants
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Change of Dose for Antihypertensive Therapy
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Average systolic blood pressure for Day 0, Day 1, and Day 2average systolic blood pressure reading on Day 0, Day 1, and Day 2
Outcome measures
| Measure |
Labetalol + Furosemide
n=4 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=7 Participants
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)
Day 0
|
138.4 mm of mercury
Standard Deviation 11.2
|
138.1 mm of mercury
Standard Deviation 9.4
|
|
Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)
Day 1
|
134.9 mm of mercury
Standard Deviation 5.4
|
138.2 mm of mercury
Standard Deviation 8.5
|
|
Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)
Day 2
|
135.2 mm of mercury
Standard Deviation 13.7
|
136.7 mm of mercury
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Average mean arterial pressure on Day 0, Day 1, and Day 2average mean arterial pressure reading on Day 0, Day 1, and Day 2
Outcome measures
| Measure |
Labetalol + Furosemide
n=4 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=7 Participants
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)
Day 0
|
102.4 mm of mercury
Standard Deviation 10.7
|
100.0 mm of mercury
Standard Deviation 9.2
|
|
Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)
Day 1
|
99.5 mm of mercury
Standard Deviation 4.7
|
100.1 mm of mercury
Standard Deviation 7.7
|
|
Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)
Day 2
|
98.0 mm of mercury
Standard Deviation 8.7
|
96.0 mm of mercury
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Average diastolic blood pressure on Day 0, Day 1, and Day 2average diastolic blood pressure reading on Day 0, Day 1, and Day 2
Outcome measures
| Measure |
Labetalol + Furosemide
n=4 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=7 Participants
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)
Day 0
|
84.1 mm of mercury
Standard Deviation 11.8
|
80.1 mm of mercury
Standard Deviation 10.4
|
|
Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)
Day 1
|
81.8 mm of mercury
Standard Deviation 4.5
|
80.7 mm of mercury
Standard Deviation 8.4
|
|
Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)
Day 2
|
78.8 mm of mercury
Standard Deviation 7.1
|
75.5 mm of mercury
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Number of days of hospital stay from randomization to dischargedays in hospital after delivery
Outcome measures
| Measure |
Labetalol + Furosemide
n=6 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=7 Participants
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Hospital Length of Stay
|
3.5 days
Standard Deviation 1.3
|
4.3 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: at 1 week postpartum visitbreastfeeding continuation after discharge
Outcome measures
| Measure |
Labetalol + Furosemide
n=4 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=6 Participants
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Breastfeeding Status
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 14 days after dischargereadmission for hypertension management
Outcome measures
| Measure |
Labetalol + Furosemide
n=6 Participants
labetalol + furosemide
furosemide: five day course of furosemide 20mg QD
labetalol: 200mg labetalol BID
|
Labetalol Only
n=7 Participants
labetalol only
labetalol: 200mg labetalol BID
|
|---|---|---|
|
Hospital Readmission
|
1 Participants
|
2 Participants
|
Adverse Events
Labetalol + Furosemide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Labetalol Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place