Labetalol vs Nifedipine for Postpartum Hypertension

Overseen By Whitney A. Booker, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Columbia University

Disqualifiers: Heart block, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 48 hours

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether labetalol or nifedipine more effectively lowers very high blood pressure in women who have just given birth. High blood pressure poses significant risks, particularly after delivery, making it crucial to identify the best treatment for new mothers. Women eligible for this trial have experienced very high blood pressure during or after pregnancy and are not currently on medication for it. The study compares an intravenous dose of labetalol with oral nifedipine to determine which is more effective. Participants will receive one of these treatments and may switch to the other if the initial treatment proves ineffective. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand how they benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should not have taken the study medications (labetalol or nifedipine) in the last 24 hours.

What is the safety track record for labetalol and nifedipine?

Research shows that taking nifedipine orally is usually safe for treating high blood pressure after childbirth. In one study, only 2.1% of patients on nifedipine required hospital readmission. Another study found that nifedipine helped prevent serious high blood pressure complications post-childbirth.

For labetalol administered through an IV, a study found no harmful effects on the mother or baby. However, another study suggested that labetalol might not be as effective as other drugs like calcium channel blockers after childbirth. Additionally, patients using labetalol had a 66% higher chance of readmission for high blood pressure issues.

Researchers are comparing both treatments to determine which better manages high blood pressure after childbirth. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for postpartum hypertension, which typically involves medications like hydralazine or methyldopa, this trial is exploring two specific treatments: oral nifedipine and intravenous labetalol. Nifedipine stands out because it's taken orally and offers a rapid onset of action, which can be crucial in emergencies. On the other hand, labetalol, given intravenously, allows for precise control over blood pressure levels, making it ideal for acute management. Researchers are excited about these treatments because they offer different administration routes and potentially faster, more controlled blood pressure reduction in postpartum hypertension cases.

What evidence suggests that this trial's treatments could be effective for postpartum hypertension?

In this trial, participants will receive either oral nifedipine or intravenous labetalol to treat high blood pressure after childbirth. Research has shown that both medications are effective in this context. One study found that these medications reached their blood pressure targets in similar numbers of patients: 44% for nifedipine and 42% for labetalol, indicating they work about equally well. However, some evidence suggests that labetalol might not be as effective as nifedipine, a calcium channel blocker, during the postpartum period. Overall, both treatments have proven effective in controlling blood pressure, making them good options for managing high blood pressure after giving birth. ^{1 2 3 6 7}

Who Is on the Research Team?

Whitney A. Booker, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for women who have recently given birth (up to 6 weeks postpartum) and are experiencing severe high blood pressure. They may have had chronic hypertension or a hypertensive disorder during pregnancy. Women with heart block, severe asthma, or recent exposure to the study medications cannot participate.

Inclusion Criteria

I have been diagnosed with chronic high blood pressure or had high blood pressure during pregnancy.

Pregnant patients with very high blood pressure (systolic BP of 160 or higher and/or diastolic BP of 110 or higher) when admitted to the hospital for childbirth.

You gave birth recently, within the last 6 weeks.

Exclusion Criteria

I do not have severe asthma or heart block.

They may not have previously had exposure to either study medication within the previous 24-hour period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Participants receive either oral nifedipine or intravenous labetalol to manage postpartum hypertensive emergencies

Up to 48 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Labetalol
• Nifedipine

Trial Overview

The study is comparing two treatments for high blood pressure in new mothers: intravenous labetalol versus oral nifedipine. It aims to determine which medication more effectively lowers dangerously high blood pressure after childbirth.

How Is the Trial Designed?

Group I: Oral Nifedipine Active Control 1 Intervention

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.

Group II: Intravenous labetalol Active Control 1 Intervention

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.

Labetalol is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Labetalol for:

• Hypertension
• Preeclampsia

Approved in United States as Labetalol for:

• Hypertension
• Preeclampsia

Approved in Canada as Labetalol for:

• Hypertension
• Preeclampsia

Approved in Japan as Labetalol for:

• Hypertension

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

In a study of 14 preeclamptic patients experiencing 55 hypertensive emergencies, oral nifedipine was found to reduce blood pressure more quickly than labetalol, taking an average of 31.30 minutes compared to 53.50 minutes (p = 0.03).

Both medications were safe, with no maternal or fetal adverse events reported, indicating that oral nifedipine is not only faster but also at least as safe as labetalol for treating hypertension in preeclampsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial of oral nifedipine and oral labetalol in preeclampsia hypertensive emergency treatment. Duro-Gómez, J., Rodríguez-Marín, AB., Giménez de Azcárete, M., et al.[2018]

Nicardipine and labetalol have similar success rates in controlling severe hypertension during pregnancy, based on a nested case control study and meta-analysis of existing data.

While nicardipine is effective, it is associated with more maternal side effects like tachycardia, headache, and nausea, whereas labetalol is linked to more neonatal side effects, including hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The optimal treatment of severe hypertension in pregnancy: update of the role of nicardipine. Nooij, LS., Visser, S., Meuleman, T., et al.[2019]

In a study of 124 postpartum women, both oral Labetalol and oral long-acting Nifedipine effectively managed hypertension, but Nifedipine achieved blood pressure control faster, averaging 30.4 hours compared to 35.6 hours for Labetalol.

While both medications were well tolerated, minor side effects were more common in the Nifedipine group, suggesting that while it may be more effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial. Ainuddin, J., Javed, F., Kazi, S.[2023]

In a study of 60 pregnant women with severe hypertension, both nicardipine and labetalol effectively lowered blood pressure by 20%, with success rates of 70% and 63% respectively, indicating both medications are viable options for treatment.

Nicardipine resulted in a greater reduction in systolic and diastolic blood pressure compared to labetalol, and both medications were well tolerated, with no cases of hypotension reported, although moderate tachycardia was noted with nicardipine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term treatment of severe hypertension of pregnancy: prospective comparison of nicardipine and labetalol. Elatrous, S., Nouira, S., Ouanes Besbes, L., et al.[2013]

In a study of 120 pregnant women with severe hypertension, oral nifedipine was found to reduce blood pressure more quickly than intravenous labetalol, taking an average of 27.25 minutes compared to 36.75 minutes for labetalol.

Nifedipine also required significantly fewer doses to achieve the target blood pressure, making it a potentially more convenient and effective option for managing severe hypertension in pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IV labetalol and oral nifedipine in acute control of severe hypertension in pregnancy-A randomized controlled trial. Zulfeen, M., Tatapudi, R., Sowjanya, R.[2019]

In a study of 112 pregnant women with chronic hypertension, both labetalol and nifedipine effectively controlled blood pressure, with no significant difference in overall efficacy between the two medications.

Nifedipine was associated with a notable reduction in central aortic pressure, while labetalol showed a significant decrease in diastolic blood pressure specifically in non-black women, suggesting potential ethnic differences in treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial. Webster, LM., Myers, JE., Nelson-Piercy, C., et al.[2022]

In a randomized controlled trial involving 50 women with persistent postpartum hypertension, both oral labetalol and oral extended release nifedipine were effective in managing blood pressure, taking a similar amount of time to achieve control (approximately 37.6 hours for labetalol and 38.2 hours for nifedipine).

Labetalol was more effective at achieving blood pressure control with the initial starting dose compared to nifedipine (76% vs. 46%), and it also had fewer minor side effects (20% vs. 48%), making it a safer option for postpartum hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. Sharma, KJ., Greene, N., Kilpatrick, SJ.[2022]

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