Trial Outcomes & Findings for Lasix for the Prevention of De Novo Postpartum Hypertension (NCT NCT04752475)

NCT ID: NCT04752475

Last Updated: 2024-12-13

Results Overview

Difference in MAP averaged over the 24 hours prior to discharge or the 24 hours prior to antihypertensive therapy initiation (whichever occurs first)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 82 participants
• Primary outcome timeframe: 24 hours prior to discharge through discharge, up to 7 days
• Results posted on: 2024-12-13

Participant Flow

Participant milestones

Measure	Lasix (Furosemide) Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Overall Study STARTED	41	41
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Lasix (Furosemide) Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Lasix for the Prevention of De Novo Postpartum Hypertension

Baseline characteristics by cohort

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=40 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days	Total n=80 Participants Total of all reporting groups
Age, Customized age < 35	17 Participants n=93 Participants	12 Participants n=4 Participants	29 Participants n=27 Participants
Age, Customized age >= 35	23 Participants n=93 Participants	28 Participants n=4 Participants	51 Participants n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	40 Participants n=4 Participants	80 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	12 Participants n=93 Participants	9 Participants n=4 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=93 Participants	27 Participants n=4 Participants	49 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	9 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	9 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants	0 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=93 Participants	10 Participants n=4 Participants	25 Participants n=27 Participants
Region of Enrollment United States	40 participants n=93 Participants	40 participants n=4 Participants	80 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours prior to discharge through discharge, up to 7 days

Difference in MAP averaged over the 24 hours prior to discharge or the 24 hours prior to antihypertensive therapy initiation (whichever occurs first)

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=40 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Mean Arterial Blood Pressure (MAP)	88.9 mmHg Standard Deviation 7.4	86.8 mmHg Standard Deviation 7.1

SECONDARY outcome

Timeframe: Randomization through discharge, up to 7 days

Time until discharge from the hospital

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=40 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Time to Discharge	2.0 days Interval 2.0 to 3.0	2.0 days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

Population: 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected.

Number of participants who develop de novo postpartum hypertension. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=39 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Rate of de Novo Postpartum Preeclampsia	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

Population: 1 participant in the Placebo Arm withdrew from the study before the Secondary Outcome data was collected.

Percent of recorded blood pressures that are elevated (>140 systolic OR >90 diastolic).

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=39 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Percent of Recorded Blood Pressures That Are Elevated 2 weeks postpartum	8 percent Interval 5.0 to 17.0	5 percent Interval 2.0 to 13.0
Percent of Recorded Blood Pressures That Are Elevated Discharge	4 percent Interval 0.0 to 9.0	0 percent Interval 0.0 to 6.0
Percent of Recorded Blood Pressures That Are Elevated 6 weeks postpartum	8 percent Interval 4.0 to 17.0	5 percent Interval 2.0 to 9.0

SECONDARY outcome

Timeframe: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

Population: 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected.

Number of participants who receive intravenous magnesium sulfate for seizure prophylaxis. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=39 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Rate of Magnesium Sulfate Administration	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

Population: 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected.

Number of participants receiving intravenous antihypertensive therapy and initiated on oral hypertensive therapy. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=39 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Rate of Initiation of Antihypertensives	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Discharge (up to 7 days), 2 weeks postpartum, 6 weeks postpartum

Population: 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected.

Number of participants experiencing severe maternal morbidity (e.g. seizure, stroke, Posterior reversible encephalopathy syndrome (PRES), death, etc.) This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=39 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Rate of Severe Maternal Morbidity	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 weeks postpartum, 6 weeks postpartum

Population: 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected.

Number of participants who experienced triage or ED presentation/readmission for hypertensive-related complaints. This outcome was assessed at 2 weeks postpartum and 6 weeks postpartum. Data is reported at 6 weeks postpartum.

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=39 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Rate of Triage or Emergency Department (ED) Presentation/Readmission	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 weeks postpartum, 6 weeks postpartum

Population: 1 participant in the Placebo Arm (who completed Primary Outcome) withdrew from the study before the Secondary Outcome data was collected.

Number of participants continuing to breastfeed of those who initiated breastfeeding after delivery. This outcome was assessed at Discharge (up to 7 days), 2 weeks postpartum, and 6 weeks postpartum. Data is reported at 2 weeks and 6 weeks postpartum.

Outcome measures

Measure	Lasix (Furosemide) n=40 Participants Furosemide 20 mg, oral, once daily for 5 days Furosemide: Furosemide 20 mg pill taken daily for 5 days	Placebo n=39 Participants Identical-appearing placebo, oral, once daily for 5 days Placebo: Identical-appearing placebo pill taken daily for 5 days
Breastfeeding Continuation Rate 2 weeks	5 Participants	5 Participants
Breastfeeding Continuation Rate 6 weeks	7 Participants	5 Participants

Adverse Events

Lasix (Furosemide)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Russell Miller, MD

Associate Professor of Prenatal Pediatrics at CUIMC

Phone: 212-305-3151

Email: rsm20@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place