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

Trial Summary

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 data supports the effectiveness of the drugs Labetalol and Nifedipine for postpartum hypertension?

Research shows that both Labetalol and Nifedipine are effective in controlling blood pressure in women with postpartum hypertension. In a study, both drugs were found to manage blood pressure to target levels, with no significant difference in effectiveness between them. ^{1 2 3 4 5}

Is Labetalol or Nifedipine safe for treating hypertension in pregnancy?

Research shows that both Labetalol and Nifedipine are generally safe for managing high blood pressure in pregnant women. Studies have compared their use in severe and chronic hypertension during pregnancy, indicating they effectively control blood pressure without significant safety concerns. ^{2 3 6 7 8}

How do the drugs labetalol and nifedipine differ from other treatments for postpartum hypertension?

Labetalol and nifedipine are unique in treating postpartum hypertension because they are both oral medications that can be used to quickly control high blood pressure after childbirth. Nifedipine works faster than labetalol, making it a good option for rapid blood pressure reduction, while both drugs are considered safe for mothers and babies. ^{1 3 4 5 9}

What is the purpose of this trial?

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.

Research Team

Whitney A. Booker, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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 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]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

IV labetalol and oral nifedipine in acute control of severe hypertension in pregnancy-A randomized controlled trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Postpartum medical management of hypertension and risk of readmission for hypertensive complications. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Short-term treatment of severe hypertension of pregnancy: prospective comparison of nicardipine and labetalol. [2013]

7. England pubmed.ncbi.nlm.nih.gov

The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine? [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The optimal treatment of severe hypertension in pregnancy: update of the role of nicardipine. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A trial of oral nifedipine and oral labetalol in preeclampsia hypertensive emergency treatment. [2018]