Trial Outcomes & Findings for Oral Nifedipine Versus Oral Labetalol (NCT NCT02168309)

NCT ID: NCT02168309

Last Updated: 2017-12-13

Results Overview

Primary outcome

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2017-12-13

Participant Flow

Participant milestones

Measure	Labetalol Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedipine Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Nifedipine Versus Oral Labetalol

Baseline characteristics by cohort

Measure	Labetalol n=25 Participants Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedipine n=25 Participants Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control	Total n=50 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	25 Participants n=5 Participants	25 Participants n=7 Participants	50 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	34 years STANDARD_DEVIATION 7.4 • n=5 Participants	33.3 years STANDARD_DEVIATION 6.4 • n=7 Participants	33.7 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 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	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	16 Participants n=7 Participants	33 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
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Body Mass Index	30.3 kg/m^2 STANDARD_DEVIATION 4.1 • n=5 Participants	33.0 kg/m^2 STANDARD_DEVIATION 7.8 • n=7 Participants	31.7 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Primary outcome

Outcome measures

Measure	Labetalol n=25 Participants Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedipine n=25 Participants Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control
Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication	37.6 hours Standard Deviation 32.5	38.2 hours Standard Deviation 27.6

SECONDARY outcome

Timeframe: 0-10 days

Secondary outcome

Outcome measures

Measure	Labetalol n=25 Participants Labetalol 200mg PO BID starting dose Labetalol: Titrate up for blood pressure control	Nifedipine n=25 Participants Nifedpine XL starting at dose 30mg PO daily Nifedipine: Titrate up to achieve blood pressure control
Total Length of Hospital Stay in Days	4.0 days Standard Deviation 1.5	4.3 days Standard Deviation 2.3

Adverse Events

Labetalol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nifedipine

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

Kathryn Sharma

Central Coast Perinatology

Phone: 8058980258

Email: katy.jones@gmail.com

Results disclosure agreements

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