Postpartum Pregnancy-Induced HypertensionPhase 4NCT05139238
Postpartum Hypertension Study
A Phase 4 study testing Labetalol and Nifedipine in people with Postpartum Pregnancy-Induced Hypertension and Postpartum Preeclampsia, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia, Pregnancy-Induced Hypertension in Postpartum
- What is being tested?
- Labetalol and Nifedipine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2022to 21 Aug 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to labor and delivery (L\&D) with blood pressure (BP) in severe range, defined as a systolic ≥160 mm Hg and/or diastolic ≥110 mm Hg
- Postpartum, immediately to 6 weeks postpartum
- With a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy
Who cannot join
- They may not have previously had exposure to either study medication within the previous 24-hour period.
- Patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Oral Nifedipine Versus Intravenous Labetalol for Postpartum (PP) Hypertensive Emergency: A Randomized Clinical Trial (RCT)
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.
Read the detailed description
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.
- Conditions
- Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia, Pregnancy-Induced Hypertension in Postpartum, Hypertensive Emergency
- Being tested
- Labetalol, Nifedipine
- Keywords
- Hypertension, Hypertensive Emergency, Postpartum, Preeclampsia
- Medical subject headings
- Hypertensive Crisis, Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
Intravenous labetalol, a short acting ant-hypertensive
NifedipineDrug
Also called Oral Procardia
Oral nifedipine, a short acting ant-hypertensive
| Study group | Role | What they receive |
|---|---|---|
| Oral Nifedipine | Active comparator | 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. Receives: Drug: Nifedipine |
| Intravenous labetalol | Active comparator | 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. Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 hours
Secondary outcomes (2)
Number of Recurrence of Severe Blood Pressure
The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.
Measured: Up to 48 hours
Total Number of Participants Who Need for Second Antihypertensive Agent
The need to use a second (alternative) antihypertensive medication.
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start4 Jul 2022
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Why it stopped: Principal investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postpartum Pregnancy-Induced HypertensionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Whitney A. Booker, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139238
- Sponsor's protocol ID
- AAAT5925
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2021
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nifedipine Versus Intravenous Labetalol for Postpartum (PP) Hypertensive Emergency: A Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT05139238
- Acronym / sponsor ID
- AAAT5925
- Conditions
- Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia, Pregnancy-Induced Hypertension in Postpartum, Hypertensive Emergency
- Keywords
- Hypertension, Hypertensive Emergency, Postpartum, Preeclampsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator left the institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nifedipine | Active comparator | Drug: NifedipineOral 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 | Active comparator | Drug: LabetalolIntravenous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to labor and delivery (L\&D) with blood pressure (BP) in severe range, defined as a systolic ≥160 mm Hg and/or diastolic ≥110 mm Hg
- Postpartum, immediately to 6 weeks postpartum
- With a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy
Key exclusion criteria (2 listed)
- They may not have previously had exposure to either study medication within the previous 24-hour period.
- Patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LabetalolIntravenous labetalol, a short acting ant-hypertensive | Drug | Intravenous labetalol |
| NifedipineAlso: Oral ProcardiaOral nifedipine, a short acting ant-hypertensive | Drug | Oral Nifedipine |
Primary outcome
Time to Initial Blood Pressure Control (Minutes)
Time frame: Up to 48 hours
The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of <160 mmHg systolic and <110 mmHg diastolic.
2 secondary outcomes
Number of Recurrence of Severe Blood Pressure
Time frame: Up to 48 hours
Total Number of Participants Who Need for Second Antihypertensive Agent
Time frame: Up to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Whitney A. Booker, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Labetalol and Nifedipine in people with Postpartum Pregnancy-Induced Hypertension and Postpartum Preeclampsia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Initial Blood Pressure Control (Minutes) (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.