Trial Outcomes & Findings for Postpartum Hypertension Study (NCT NCT05139238)
NCT ID: NCT05139238
Last Updated: 2026-05-06
Results Overview
The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of \<160 mmHg systolic and \<110 mmHg diastolic.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
Up to 48 hours
Results posted on
2026-05-06
Participant Flow
0 participants crossed over to receive the other intervention
Participant milestones
| Measure |
Oral Nifedipine
Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of \<160 systolic and \<105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
Intravenous Labetalol
Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postpartum Hypertension Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 48 hoursThe primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of \<160 mmHg systolic and \<110 mmHg diastolic.
Outcome measures
| Measure |
Oral Nifedipine
n=1 Participants
Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of \<160 systolic and \<105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
Intravenous Labetalol
n=1 Participants
Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
|---|---|---|
|
Time to Initial Blood Pressure Control (Minutes)
|
15 minutes
|
6 minutes
|
SECONDARY outcome
Timeframe: Up to 48 hoursThe number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.
Outcome measures
| Measure |
Oral Nifedipine
n=1 Participants
Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of \<160 systolic and \<105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
Intravenous Labetalol
n=1 Participants
Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
|---|---|---|
|
Number of Recurrence of Severe Blood Pressure
|
2 recurrence of severe blood pressure
|
2 recurrence of severe blood pressure
|
SECONDARY outcome
Timeframe: Up to 48 hoursThe need to use a second (alternative) antihypertensive medication.
Outcome measures
| Measure |
Oral Nifedipine
n=1 Participants
Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of \<160 systolic and \<105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
Intravenous Labetalol
n=1 Participants
Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
|
|---|---|---|
|
Total Number of Participants Who Need for Second Antihypertensive Agent
|
0 Participants
|
0 Participants
|
Adverse Events
Oral Nifedipine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Labetalol
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place