110 Participants NeededMy employer runs this trial

Labetalol vs Nifedipine for High Blood Pressure After Pregnancy

(PEACE Trial)

TA
SS
Overseen BySonia S Raghuram, MS
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: University of California, Los Angeles
Must be taking: Oral antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether labetalol or extended-release nifedipine better controls high blood pressure after childbirth. Researchers believe that nifedipine might maintain lower blood pressure and reduce the need for long-term medication. Participants will be randomly assigned to one of the medications and will have their blood pressure monitored remotely. This study suits those who have experienced high blood pressure after delivery and require medication for management. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants the chance to benefit from established medications while contributing to research that enhances understanding of their benefits.

Do I have to stop taking my current medications for the trial?

The trial requires that participants have not been treated with oral antihypertensive medications before delivery. If you are currently on such medications, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that both labetalol and nifedipine are generally safe for treating high blood pressure after childbirth. Labetalol has been used safely in new mothers, though some studies suggest it might not be as effective as nifedipine. While there are no major safety concerns for labetalol, monitoring for potential risks remains important.

Nifedipine, however, is known to lower the chance of hospital readmission due to high blood pressure after giving birth. Studies have found it to be a safe option for managing high blood pressure in new mothers, with fewer reported issues.

Overall, both medications are well-tolerated, but nifedipine may slightly reduce the risk of hospital readmissions. Participants considering these treatments can feel reassured by the available safety data.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for postpartum hypertension, which often include beta-blockers and calcium channel blockers, Labetalol and Nifedipine offer unique benefits. Labetalol is a combined alpha and beta-blocker, providing a dual mechanism of action that can effectively lower blood pressure by reducing heart rate and dilating blood vessels. Nifedipine, on the other hand, is an extended-release calcium channel blocker that allows for once-daily dosing, potentially improving adherence and convenience. Researchers are excited about these treatments because they offer targeted approaches that could optimize blood pressure control with potentially fewer side effects.

What evidence suggests that this trial's treatments could be effective for postpartum high blood pressure?

This trial will compare the effectiveness of labetalol and nifedipine for managing high blood pressure after pregnancy. Studies have shown that both medications can help manage this condition. However, research suggests that nifedipine might be more effective. Specifically, patients discharged with nifedipine were 88% less likely to be readmitted compared to those taking labetalol. Additionally, labetalol has been associated with a higher likelihood of hospital readmission after childbirth. Overall, nifedipine appears to offer better control of high blood pressure post-pregnancy and may reduce the need for additional treatment.34678

Are You a Good Fit for This Trial?

This trial is for women who have recently given birth and are experiencing high blood pressure after delivery. Participants must be able to take oral medication and use remote blood pressure monitoring.

Inclusion Criteria

Delivery at study institution at ≥28 weeks gestation
Postpartum SBP > 150 and/or DBP > 100 OR 2 or more SBP > 140 and/or DBP > 90 within a 24-hour period
I am 18 years old or older.
See 2 more

Exclusion Criteria

Unable to provide written informed consent in English
I am allergic to nifedipine or labetalol.
I have a history of serious asthma, COPD, heart failure, or significant heart block.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either oral labetalol or oral extended-release nifedipine to manage postpartum hypertension, with remote blood pressure monitoring and medication adjustments as needed

6 weeks
Remote monitoring with daily logs, follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on continuation of antihypertensive medication beyond 6 weeks postpartum

4 weeks
Follow-up visits with research team and primary obstetrician

What Are the Treatments Tested in This Trial?

Interventions

  • Labetalol
  • Nifedipine

Trial Overview

The study compares two medications, labetalol and extended-release nifedipine, to see which better controls postpartum high blood pressure. Participants are randomly assigned to one of the two drugs and monitored remotely.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: NifedipineExperimental Treatment1 Intervention
Group II: LabetalolExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Citations

Hypertension in Pregnancy and Postpartum - PMC - NIH

In addition, recent data suggest that labetalol may be less effective in the postpartum period compared with calcium channel blockers and may be associated with ...

Oral Nifedipine Versus Labetalol in Treatment of ...

Research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to ...

Comparative Effectiveness and Safety of Labetalol Versus ...

The effectiveness outcome occurred in 42% in the labetalol group and 44% in the nifedipine group, with an adjusted RR of 1.03 (95% CI: 0.96-1.11) and an ...

Antihypertensive Treatment for Postpartum Hypertension ...

Labetalol is another option for treating high blood pressure after childbirth, but some studies suggest it might not be as effective as nifedipine. For instance ...

Postpartum medical management of hypertension and risk ...

Labetalol monotherapy was associated with increased risk of readmission [aOR 1.66 (1.06–2.61)]. Conclusion: The risk of postpartum readmission for hypertensive ...

Postpartum hypertension - PMC - NIH

All listed drugs are considered safe for breastfeeding. Postpartum hypertension may persist for several weeks Gestational hypertension and preeclampsia usually ...

Hypertension in Pregnancy and Postpartum

In addition, recent data suggest that labetalol may be less effective in the postpartum period compared with calcium channel blockers and may be ...

Latest findings on labetalol in severe hypertension during ...

The drug seems to be slightly less effective in blood pressure normalization than nifedipine, with inconclusive data about safety to the mother ...