A Phase 4 interventional study of Labetalol and Nifedipine in Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia and Pregnancy-Induced Hypertension in Postpartum, sponsored by Columbia University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Columbia University · Phase 4, Interventional, and Treatment
The purpose of this study is to assess which blood pressure medication (intravenous labetalol or oral nifedipine) works better in treating severely elevated blood pressure in women who have just delivered a baby.
Hypertensive emergencies cause significant maternal morbidity and mortality in the postpartum period. In order to reduced these risks, the recommendation is to treat women with severe range blood pressure with either intravenous labetalol or oral nifedipine; it is unclear which medication is superior. The objective of this study is to prospectively enroll women who have hypertensive emergencies in the postpartum period; women will be randomized in a 1:1 fashion and treated with one of the two antihypertensives to see which one works better.
35 studies on the registry are indexed under Hypertensive Crisis; 9 are open to participants now.
This study's enrollment of 2 is below the median of 135 across 22 interventional studies indexed under Hypertensive Crisis.
Browse Hypertensive Crisis studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
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.
Drug: Nifedipine
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.
Drug: Labetalol
Intravenous labetalol, a short acting ant-hypertensive
Oral nifedipine, a short acting ant-hypertensive
Also known as: Oral Procardia
Time to Initial Blood Pressure Control (Minutes)
The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of \<160 mmHg systolic and \<110 mmHg diastolic.
Time frame: Up to 48 hours
Number of Recurrence of Severe Blood Pressure
The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.
Time frame: Up to 48 hours
Total Number of Participants Who Need for Second Antihypertensive Agent
The need to use a second (alternative) antihypertensive medication.
Time frame: Up to 48 hours
| Milestone | Oral Nifedipine | Intravenous Labetalol |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of \<160 mmHg systolic and \<110 mmHg diastolic.
| minutes | Oral Nifedipine | Intravenous Labetalol |
|---|---|---|
| Time to Initial Blood Pressure Control (Minutes) | 15 | 6 |
The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.
| recurrence of severe blood pressure | Oral Nifedipine | Intravenous Labetalol |
|---|---|---|
| Number of Recurrence of Severe Blood Pressure | 2 | 2 |
The need to use a second (alternative) antihypertensive medication.
| Participants | Oral Nifedipine | Intravenous Labetalol |
|---|---|---|
| Total Number of Participants Who Need for Second Antihypertensive Agent | 0 | 0 |
Collected over Up to 48 hours after receiving the study intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Nifedipine | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Intravenous Labetalol | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Due to only one participant being enrolled in each arm, data was not analyzed or disclosed in an effort to protect participant confidentiality.
| Age, Categorical | Oral Nifedipine | Intravenous Labetalol | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Sex: Female, Male | Oral Nifedipine | Intravenous Labetalol | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | Oral Nifedipine | Intravenous Labetalol | Total |
|---|
| Region of Enrollment(participants) | Oral Nifedipine | Intravenous Labetalol | Total |
|---|
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