Trial Outcomes & Findings for Furosemide for Accelerated Recovery of Blood Pressure Postpartum (NCT NCT03556761)

NCT ID: NCT03556761

Last Updated: 2020-09-10

Results Overview

To compare the rate of persistently elevated blood pressures (\>140/90) in women that receive a five day furosemide course compared to those that receive placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 384 participants
• Primary outcome timeframe: 0-7 days postpartum
• Results posted on: 2020-09-10

Participant Flow

Participant milestones

Measure	Oral Furosemide Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Overall Study STARTED	192	192
Overall Study COMPLETED	168	163
Overall Study NOT COMPLETED	24	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Furosemide for Accelerated Recovery of Blood Pressure Postpartum

Baseline characteristics by cohort

Measure	Oral Furosemide n=192 Participants Oral tablet of furosemide 20 mg once daily for a total of 5 consecutive doses.	Placebo Oral Tablet n=192 Participants Oral tablet of placebo once daily for a total of 5 consecutive doses.	Total n=384 Participants Total of all reporting groups
Age, Continuous	27 years n=5 Participants	27 years n=7 Participants	27 years n=5 Participants
Sex: Female, Male Female	192 Participants n=5 Participants	192 Participants n=7 Participants	384 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	151 Participants n=5 Participants	138 Participants n=7 Participants	289 Participants n=5 Participants
Race/Ethnicity, Customized White	30 Participants n=5 Participants	47 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Hypertensive Disorders of Pregnancy (HDP) Non-severe	128 Participants n=5 Participants	133 Participants n=7 Participants	261 Participants n=5 Participants
Hypertensive Disorders of Pregnancy (HDP) Severe	64 Participants n=5 Participants	59 Participants n=7 Participants	123 Participants n=5 Participants
Gestational age at delivery	38.6 weeks n=5 Participants	38.4 weeks n=7 Participants	38.5 weeks n=5 Participants
Cesarean delivery	55 participants n=5 Participants	38 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-7 days postpartum

To compare the rate of persistently elevated blood pressures (>140/90) in women that receive a five day furosemide course compared to those that receive placebo.

Outcome measures

Measure	Oral Furosemide n=168 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=163 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Persistently Elevated Blood Pressures 7 Days Postpartum	10 Participants	23 Participants

PRIMARY outcome

Timeframe: 0-14 days postpartum

To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.

Outcome measures

Measure	Oral Furosemide n=168 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=163 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Time to Resolution	10 days Interval 6.25 to 12.5	10.5 days Interval 6.5 to 12.5

SECONDARY outcome

Timeframe: 0-6 weeks postpartum

Number of subjects with one or more readmission/ER visit that were hypertension related

Outcome measures

Measure	Oral Furosemide n=168 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=163 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Postpartum Readmission	9 Participants	16 Participants

SECONDARY outcome

Timeframe: 0-6 weeks postpartum

Number of women who had severe hypertension (systolic blood pressure>160 millimeters of mercury or diastolic blood pressure>110 millimeters of mercury) postpartum

Outcome measures

Measure	Oral Furosemide n=168 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=163 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Number of Subjects Who Had Severe Hypertension Postpartum	81 Participants	86 Participants

SECONDARY outcome

Timeframe: 0-6 weeks postpartum

Number of days postpartum participants stayed in the hospital

Outcome measures

Measure	Oral Furosemide n=168 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=163 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Postpartum Length of Stay	2 Days Interval 2.0 to 3.0	2 Days Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: 0-6 weeks postpartum

Subjects with complications during hospitalization related to hypertensive disorders of pregnancy.

Outcome measures

Measure	Oral Furosemide n=192 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=192 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Subjects With Complications During Hospitalization	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-6 weeks postpartum

Number of subjects experiencing one or more adverse effects secondary to furosemide

Outcome measures

Measure	Oral Furosemide n=192 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=192 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Number of Subjects Experiencing One or More Adverse Effects	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 0 to 6 weeks post-partum

Number of subjects that required additional hypertensive medication after discharge

Outcome measures

Measure	Oral Furosemide n=192 Participants Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=192 Participants Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Number of Subjects That Required for Additional Antihypertensives	25 Participants	39 Participants

Adverse Events

Oral Furosemide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Oral Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oral Furosemide n=192 participants at risk Oral furosemide 20 mg/day for a total of 5 consecutive doses. Oral furosemide: Furosemide (Lasix), 20 milligram, PO, PO, daily	Placebo Oral Tablet n=192 participants at risk Placebo once per day for a total of 5 consecutive doses. Placebo Oral Tablet: Placebo, PO, daily
Pregnancy, puerperium and perinatal conditions Pulmonary edema	1.6% 3/192 • Number of events 3 • Over 6 weeks postpartum	0.52% 1/192 • Number of events 1 • Over 6 weeks postpartum

Additional Information

Dr Lisa Levine

University of Pennsylvania

Phone: 215-662-6913

Email: lisa.levine@pennmedicine.upenn.edu

Results disclosure agreements

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