Trial Outcomes & Findings for Furosemide vs. Placebo for Severe Antepartum Hypertension (NCT NCT04615624)

Results Overview

Mean systolic blood pressure during hour after study drug administration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

65 participants

Primary outcome timeframe

0 minutes to 60 minutes post-dose

Results posted on

2024-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Furosemide When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Overall Study STARTED	33	32
Overall Study COMPLETED	33	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Furosemide vs. Placebo for Severe Antepartum Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline	Total n=65 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	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Sex · Female	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Sex/Gender, Customized Sex · Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Filipino	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Micronesian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · All others	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
obese	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
insurance Commercial	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
insurance Public	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
nulliparous	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
twin pregnancy	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
hypertension subtype new-onset	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
hypertension subtype pre-existing	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 minutes to 60 minutes post-dose

Mean systolic blood pressure during hour after study drug administration.

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Mean Systolic Blood Pressure During Hour After Study Drug	147 mmHg Standard Deviation 14.8	152 mmHg Standard Deviation 13.8

SECONDARY outcome

Timeframe: 0 minutes to 60 minutes post-dose

Mean diastolic blood pressure during the 1-hour period after drug administration.

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Mean Diastolic Blood Pressure During Hour After Study Drug	88 mmHg Standard Deviation 10.8	87 mmHg Standard Deviation 9.3

SECONDARY outcome

Timeframe: 0 minutes to 1 hour post-dose

Change from qualifying systolic blood pressure (qualifying SBP-mean SBP during hour after intervention) where qualifying systolic blood pressure refers to a severe range SBP (\>=160 millimeters of mercury (mmHg)) for at least 15 minutes.

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Change From Qualifying Systolic Blood Pressure	-26 mmHg Standard Deviation 13.9	-24 mmHg Standard Deviation 15.5

SECONDARY outcome

Timeframe: 0 minutes to 1 hour post-dose

Change from qualifying diastolic blood pressure (qualifying DBP-mean DBP during hour after intervention) where qualifying diastolic blood pressure refers to a severe range DBP (\>=110 millimeters of mercury (mmHg)) for at least 15 minutes.

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Change From Qualifying Diastolic Blood Pressure	-12 mmHg Standard Deviation 7.6	-11 mmHg Standard Deviation 8.9

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Not every participant had their blood pressure and thus pulse pressure checked at 2 hours which is a limitation of the study.

Pulse pressure at 2 hours after study drug.

Outcome measures

Outcome measures
Measure	Furosemide n=27 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=22 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Pulse Pressure at 2 Hours After Study Drug.	55 mmHg Standard Deviation 12.5	67 mmHg Standard Deviation 15.1

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Not every participant had their blood pressure checked at 2 hours which is a limitation of the study.

Systolic blood pressure at 2 hours after study drug

Outcome measures

Outcome measures
Measure	Furosemide n=27 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=22 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Systolic Blood Pressure at 2 Hours After Study Drug	139 mmHg Standard Deviation 18.5	154 mmHg Standard Deviation 18.4

SECONDARY outcome

Timeframe: 2 hours post-dose

Population: Not every participant had their blood pressure checked at 2 hours which is a limitation of the study.

Diastolic blood pressure at 2 hours after study drug

Outcome measures

Outcome measures
Measure	Furosemide n=27 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=22 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Diastolic Blood Pressure at 2 Hours After Study Drug	84 mmHg Standard Deviation 12.5	87 mmHg Standard Deviation 10.5

OTHER_PRE_SPECIFIED outcome

Timeframe: at the time of birth

Gestational age in weeks and days at the time of birth

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Gestational Age at Delivery	34.1 weeks Standard Deviation 2.9	34 weeks Standard Deviation 3.1

OTHER_PRE_SPECIFIED outcome

Timeframe: at the time of delivery

Time in days and hours from admission to birth

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Time From Admission to Delivery	2.3 days Interval 1.1 to 14.6	3.7 days Interval 1.1 to 11.2

OTHER_PRE_SPECIFIED outcome

Timeframe: at the time of delivery

Time in days and hours from treatment to birth

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Time From Treatment to Delivery	2.1 days Interval 0.8 to 10.9	1.8 days Interval 0.7 to 6.5

OTHER_PRE_SPECIFIED outcome

Timeframe: at the time of induction of labor

Number of women who required induction of labor

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Induction of Labor	7 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of delivery

Type of delivery

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Mode of Delivery spontaneous vaginal delivery	9 Participants	8 Participants
Mode of Delivery operative vaginal delivery	0 Participants	2 Participants
Mode of Delivery Cesarean section	24 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of hospital discharge

Number of women who developed seizure

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Eclampsia	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at 5 minutes after delivery

Neonatal clinical assessment (Apgar is not an abbreviated term). Minimum value 0; maximum value 9; Tool is used for assessment and not an accurate prognostic tool to predict outcomes.

Outcome measures

Outcome measures
Measure	Furosemide n=35 neonates When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=34 neonates When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Low Apgar Scores of Neonate (Apgar Score <7 at 5 Min)	3 neonates	3 neonates

OTHER_PRE_SPECIFIED outcome

Timeframe: assessed from time of delivery until discharge since neonates can be admitted to the NICU at any time during this interval if issues arise.

Neonatal Intensive Care Unit admission

Outcome measures

Outcome measures
Measure	Furosemide n=35 neonates When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=34 neonates When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Newborns Admitted to Intensive Care Nursery	24 neonates	25 neonates

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed from time of severe range blood pressure to time at resolution of severe range blood pressure. Reported at time of resolution of severe range blood pressure.

Time to achieve first non-severe BP (m)

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Time to Achieve First Non-severe BP (m)	44 minutes Interval 23.0 to 75.0	46 minutes Interval 30.0 to 76.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed from 0 minutes to 1 hour post-dose, 1-hour post-dose reported

Were any additional antihypertensive agents in hour after allocation

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Number of Participants Who Required Additional Antihypertensive Agents in an Hour After Allocation	9 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 minutes to delivery of baby (72 hours post-dose)

Population: Those who required additional medication (not all participants required additional antihypertensive medication).

time until next first-line antepartum antihypertensive agent given

Outcome measures

Outcome measures
Measure	Furosemide n=23 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=22 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Latency Until Next First-line Antepartum Antihypertensive Agents	10.8 hours Interval 0.8 to 31.1	3.2 hours Interval 0.4 to 25.9

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of hospital discharge

proportion of participants who were discharged prior to delivery of the baby

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Discharged Without Delivery	6 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of hospital discharge

length of stay

Outcome measures

Outcome measures
Measure	Furosemide n=33 Participants When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=32 Participants When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Length of Stay	6.1 days Interval 4.3 to 12.5	7.3 days Interval 4.1 to 7.3

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of birth

weight of baby at birth

Outcome measures

Outcome measures
Measure	Furosemide n=35 neonates When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive. Furosemide: Furosemide, a loop diuretic	Placebo n=34 neonates When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive. Placebo: Normal saline
Birthweight	1921 grams Standard Deviation 534.7	2070 grams Standard Deviation 796.4

Adverse Events

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

Melanie Maykin

University of Hawaii and Hawaii Pacific Health

Phone: 8089836000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place