Trial Outcomes & Findings for Response to Anti-hypertensives in Pregnant and Postpartum Patients (NCT NCT03506724)
NCT ID: NCT03506724
Last Updated: 2021-05-24
Results Overview
Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour
Results posted on
2021-05-24
Participant Flow
This trial was conducted at two urban academic institutions with participants enrolled from September 2017 to April 2019.
Participant milestones
| Measure |
Oral Nifedipine
Oral medication 10mg and 20mg
Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed.
|
Intravenous Labetalol
Intravenous medication 20mg, 40mg, 80 mg
Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
55
|
|
Overall Study
COMPLETED
|
54
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data for participants pregnant at baseline
Baseline characteristics by cohort
| Measure |
Intravenous Labetalol
n=55 Participants
intravenous medication 20mg, 40mg, 80 mg
Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol.
|
Oral Nifedipine
n=54 Participants
Oral medication 10mg and 20mg
Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.49 years
STANDARD_DEVIATION 6.25 • n=55 Participants
|
33.67 years
STANDARD_DEVIATION 5.74 • n=54 Participants
|
34.59 years
STANDARD_DEVIATION 6.05 • n=109 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=55 Participants
|
54 Participants
n=54 Participants
|
109 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=55 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 Participants
n=55 Participants
|
22 Participants
n=54 Participants
|
42 Participants
n=109 Participants
|
|
Race/Ethnicity, Customized
White, Asian, or Hispanic
|
35 Participants
n=55 Participants
|
32 Participants
n=54 Participants
|
67 Participants
n=109 Participants
|
|
Body Mass Index (BMI)
|
27.89 kg/m^2
STANDARD_DEVIATION 6.36 • n=55 Participants
|
29.84 kg/m^2
STANDARD_DEVIATION 6.54 • n=54 Participants
|
28.86 kg/m^2
STANDARD_DEVIATION 6.50 • n=109 Participants
|
|
Gestational age
|
37.4 weeks
n=53 Participants • Data for participants pregnant at baseline
|
36.9 weeks
n=49 Participants • Data for participants pregnant at baseline
|
37.1 weeks
n=102 Participants • Data for participants pregnant at baseline
|
|
Number of participants who are Post-partum
|
2 Participants
n=55 Participants
|
5 Participants
n=54 Participants
|
7 Participants
n=109 Participants
|
|
Number of Participants with Chronic Hypertension (CHTN)
|
9 Participants
n=55 Participants
|
9 Participants
n=54 Participants
|
18 Participants
n=109 Participants
|
|
Number of Participants with Gestational Hypertension (GHTN)
|
12 Participants
n=55 Participants
|
14 Participants
n=54 Participants
|
26 Participants
n=109 Participants
|
|
Number of Participants with Diabete Mellitus Type I or II
|
2 Participants
n=55 Participants
|
2 Participants
n=54 Participants
|
4 Participants
n=109 Participants
|
|
Family History of HTN
|
26 Participants
n=55 Participants
|
29 Participants
n=54 Participants
|
55 Participants
n=109 Participants
|
|
History of Smoking
|
9 Participants
n=55 Participants
|
12 Participants
n=54 Participants
|
21 Participants
n=109 Participants
|
|
Pre-medication, Systolic Blood Pressure
|
173.96 mmHg
STANDARD_DEVIATION 12.74 • n=55 Participants
|
171.74 mmHg
STANDARD_DEVIATION 11.19 • n=54 Participants
|
172.86 mmHg
STANDARD_DEVIATION 11.99 • n=109 Participants
|
|
Pre-medication, DiastolicBlood Pressure
|
94.18 mmHg
STANDARD_DEVIATION 10.02 • n=55 Participants
|
97.09 mmHg
STANDARD_DEVIATION 10.28 • n=54 Participants
|
95.62 mmHg
STANDARD_DEVIATION 10.21 • n=109 Participants
|
PRIMARY outcome
Timeframe: Ten minute intervals from the time of the first severe range blood pressure, up to 1 hourTime to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Outcome measures
| Measure |
Intravenous Labetalol
n=55 Participants
intravenous medication 20mg, 40mg, 80 mg
Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol.
|
Oral Nifedipine
n=54 Participants
Oral medication 10mg and 20mg
Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed.
|
|---|---|---|
|
Time to Achieve Non Severe Range Blood Pressure
|
10 minutes
Interval 10.0 to 20.0
|
20 minutes
Interval 20.0 to 30.0
|
PRIMARY outcome
Timeframe: up to 1 hourPopulation: participants by ethnicity
Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Outcome measures
| Measure |
Intravenous Labetalol
n=55 Participants
intravenous medication 20mg, 40mg, 80 mg
Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol.
|
Oral Nifedipine
n=54 Participants
Oral medication 10mg and 20mg
Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed.
|
|---|---|---|
|
Number of Participants to Achieve Non Severe Range Blood Pressure
White, Asian, and Hispanic
|
33 Participants
|
31 Participants
|
|
Number of Participants to Achieve Non Severe Range Blood Pressure
Black
|
18 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: data not collected
the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed 10 minutes to 1 hour after medication is givenNumber of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine
Outcome measures
| Measure |
Intravenous Labetalol
n=55 Participants
intravenous medication 20mg, 40mg, 80 mg
Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol.
|
Oral Nifedipine
n=54 Participants
Oral medication 10mg and 20mg
Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed.
|
|---|---|---|
|
Number of Participants With Medication Side Effects
Headache
|
6 Participants
|
10 Participants
|
|
Number of Participants With Medication Side Effects
Nausea
|
3 Participants
|
7 Participants
|
|
Number of Participants With Medication Side Effects
Flushing
|
7 Participants
|
7 Participants
|
|
Number of Participants With Medication Side Effects
Any of the above
|
18 Participants
|
15 Participants
|
|
Number of Participants With Medication Side Effects
Vomiting
|
2 Participants
|
3 Participants
|
|
Number of Participants With Medication Side Effects
Dizziness
|
8 Participants
|
4 Participants
|
Adverse Events
Intravenous Labetalol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Nifedipine
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 |
Intravenous Labetalol
n=55 participants at risk
intravenous medication 20mg, 40mg, 80 mg
Labetalol: Labetalol 20mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV given over 2 minutes and the MAP calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication chosen based on institution specific protocol.
|
Oral Nifedipine
n=54 participants at risk
Oral medication 10mg and 20mg
Nifedipine: Nifedipine 10mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral given and the MAP calculated 20 minutes after medication is given and institution specific protocol performed.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
symptomatic hypotenstion
|
0.00%
0/55 • 1 hour
|
1.9%
1/54 • 1 hour
|
Additional Information
Dr. Dyese Taylor
Icahn School of Medicine at Mount Sinai
Phone: 973-926-5508
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place