Nifedipine vs Labetalol for Postpartum Hypertension

(SCARPH Trial)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Loma Linda University

Disqualifiers: Asthma, Coronary artery disease, Heart failure, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this investigator-initiated randomized control trial is to determine whether oral Nifedipine versus oral Labetalol is superior in controlling high blood pressures in the postpartum period.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that both Nifedipine and Labetalol are effective in controlling high blood pressure after childbirth. Nifedipine works faster in emergencies, while both drugs are safe and help manage blood pressure effectively. ^{1 2 3 4 5}

Is it safe to use Nifedipine or Labetalol for postpartum hypertension?

Research shows that both oral nifedipine and labetalol are generally safe for treating high blood pressure in pregnancy-related conditions, with no major adverse events reported in studies. Nifedipine works faster, but both medications effectively manage blood pressure without significant safety concerns. ^{1 2 4 5 6}

What makes the drugs nifedipine and labetalol unique for treating postpartum hypertension?

Nifedipine and labetalol are unique for treating postpartum hypertension because they are both oral medications that can be used to quickly lower high blood pressure after childbirth. Nifedipine works faster than labetalol, making it a potentially better option for rapid blood pressure control. ^{1 2 5 6 7}

Research Team

Eligibility Criteria

This trial is for women who have high blood pressure after childbirth (postpartum hypertension). They must need medication to control their blood pressure, which is defined as having a systolic BP of at least 140mmHg or diastolic BP of at least 90mmHg. Women with certain heart conditions, asthma, or contraindications to the study drugs cannot participate.

Inclusion Criteria

If you recently had a baby and your blood pressure is too high, you will not be able to join the study.

I developed high blood pressure after giving birth or need medication for it.

I am female.

Exclusion Criteria

My first language is not English or Spanish.

Your heart rate is lower than 60 or higher than 110.

I have a history of asthma, heart disease, or fluid in my lungs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral Nifedipine or oral Labetalol for blood pressure control in the postpartum period

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the need for a second antihypertensive agent

6 weeks

Treatment Details

Interventions

• Oral Labetalol (Beta Blocker)
• Oral Nifedipine (Calcium Channel Blocker)

Trial Overview The trial aims to find out if oral Nifedipine or oral Labetalol is better for managing high blood pressure in women after they've given birth. It's a randomized control trial, meaning participants are randomly assigned one of these medications to compare effectiveness.

Participant Groups

Group I: Oral Nifedipine Active Control 1 Intervention

Participants will receive oral nifedipine for blood pressure control. Dosage may initially start at one 10mg capsule by mouth three times per 24 hours (total of 30mg a day), however dosage may be increased by 30mg increments (i.e. 20mg capsule three times a day for a total of 60mg a day). Maximum dosage for oral Nifedipine will be 120mg per day.

Group II: Oral Labetalol Active Control 1 Intervention

Participants will receive oral labetalol for blood pressure control. Dosage may initially start at one 200mg tablet by mouth two times per 12 hours (total of 400mg every a day), however dosage may be increased by 100-200mg increments at a time. Maximum dosage for oral labetalol will be 2400mg per day.

Oral Labetalol is already approved in Canada for the following indications:

Approved in Canada as Labetalol for:

• Hypertension
• Postpartum hypertension

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Adrian Cotton

Loma Linda University

Chief Medical Officer since 2020

MD

Richard H. Hart

Loma Linda University

Chief Executive Officer since 2015

MD, DrPH

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 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 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 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]

Oral nifedipine and intravenous labetalol were equally effective in managing acute severe hypertension in pregnancy, showing no significant differences in blood pressure outcomes or adverse events.

However, oral nifedipine resulted in a shorter time to reach target blood pressure and required fewer doses compared to intravenous labetalol, making it a more convenient option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nifedipine may be a preferential option for treating acute severe hypertension during pregnancy: a meta-analysis. Ou, M., Zhang, F., Cui, S., et al.[2023]

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. Ireland pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

5. England pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Oral nifedipine versus intravenous labetalol for severe hypertension during pregnancy: a systematic review and meta-analysis. [2022]

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

Oral nifedipine may be a preferential option for treating acute severe hypertension during pregnancy: a meta-analysis. [2023]