Nifedipine vs Labetalol for Postpartum Hypertension

(SCARPH Trial)

Overseen By Nikia Gray-Hutto, RN, CCRP

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Loma Linda University

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

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Nifedipine or Labetalol better controls high blood pressure in women after childbirth. Participants will take these medications orally to determine which is most effective for postpartum hypertension. Women with high blood pressure after delivery who require medication may be suitable for this trial. Participants will use either Nifedipine or Labetalol to manage their blood pressure. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to research that could establish a new standard of care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Nifedipine and Labetalol have been studied for treating high blood pressure after childbirth. Studies on Nifedipine are promising. Patients taking Nifedipine had a lower chance of needing to return to the hospital for high blood pressure after giving birth. Another study found it safe for breastfeeding mothers.

Labetalol has mixed results. Some research suggests it might not work as well as Nifedipine after childbirth. Patients using Labetalol faced a higher risk of needing to return to the hospital for high blood pressure. However, Labetalol remains effective for managing severe high blood pressure during pregnancy and in other situations.

Both medications can be successful, but Nifedipine might be slightly safer and more effective right after childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for postpartum hypertension focus on managing blood pressure with medications like hydralazine or methyldopa. But in this trial, researchers are exploring oral nifedipine and oral labetalol, which have distinct advantages. Oral nifedipine stands out because it offers flexible dosing, allowing for adjustments in 30mg increments up to 120mg per day, which can be tailored to the patient's needs. Oral labetalol, on the other hand, offers quick and effective blood pressure control with the possibility of increasing the dose up to 2400mg per day. Researchers are excited about these treatments because they might provide more effective and personalized options for managing postpartum hypertension compared to traditional therapies.

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

This trial will compare oral nifedipine and oral labetalol for managing high blood pressure after childbirth. Research has shown that both treatments are effective. One study found that participants in the nifedipine arm experienced fewer hospital readmissions for high blood pressure. Another study indicated that while both medications control blood pressure, nifedipine might not act as quickly as labetalol. However, real-world evidence often supports using nifedipine as the first choice for treatment. Both medications are generally well tolerated and offer effective options for managing blood pressure after giving birth. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Oral Labetalol
• Oral Nifedipine

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Labetalol for:

• Hypertension
• Postpartum hypertension

Approved in European Union as Labetalol for:

• Hypertension
• Postpartum hypertension

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+

Published Research Related to This Trial

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]

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]

Oral nifedipine was found to have a lower risk of persistent hypertension and fewer reported maternal side effects compared to intravenous labetalol, based on a pooled analysis of seven trials involving 363 woman-infant pairs.

Despite these findings, the significance of the lower risk for persistent hypertension was not consistent across all analyses, suggesting that while nifedipine is a safe and effective alternative, further research is needed to confirm its advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nifedipine versus intravenous labetalol for severe hypertension during pregnancy: a systematic review and meta-analysis. Shekhar, S., Gupta, N., Kirubakaran, R., 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]

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 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]

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]

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