300 Participants Needed

Antihypertensive Treatment for Postpartum Hypertension

(P-PAT Trial)

MC
AP
Overseen ByAnna Palatnik, MD
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Medical College of Wisconsin
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

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

Research shows that both Labetalol and Nifedipine effectively control blood pressure in pregnant women with chronic hypertension, with similar outcomes in mean blood pressure levels. Additionally, Labetalol may offer a slight advantage in reducing diastolic blood pressure in non-black women compared to Nifedipine.12345

Is the treatment for postpartum hypertension safe?

Labetalol and nifedipine are considered safe for use in pregnancy and postpartum hypertension, as they have been studied for managing high blood pressure in pregnant women. These medications are generally well-tolerated and are commonly used to control severe hypertension during and after pregnancy.24567

How does the drug Labetalol differ from Nifedipine for postpartum hypertension?

Labetalol and Nifedipine are both used to manage postpartum hypertension, but they work differently. Labetalol is a beta-blocker that helps slow the heart rate, while Nifedipine is a calcium channel blocker that relaxes blood vessels. Studies suggest that Nifedipine may control blood pressure faster, but Labetalol might be needed less often after discharge.3891011

What is the purpose of this trial?

The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.

Eligibility Criteria

This trial is for women over 18 who were diagnosed with preeclampsia during or immediately after pregnancy and have high blood pressure postpartum. It's not for those with chronic hypertension, a late diagnosis of preeclampsia, or mostly normal blood pressures after delivery.

Inclusion Criteria

You gave birth within the last 96 hours.
I was diagnosed with preeclampsia during or right after my pregnancy.
More than 30% of your blood pressure readings after giving birth were high (systolic 140 or higher OR diastolic 90 or higher).

Exclusion Criteria

I started blood pressure medication after giving birth due to high readings.
I was diagnosed with preeclampsia after leaving the hospital from giving birth.
I have long-term high blood pressure and now also have preeclampsia.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive antihypertensive medication postpartum, with specific medication prescribed based on allergies and clinical appropriateness

6 weeks
2 visits (in-person) at 7-10 days and 6 weeks postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure checks and postpartum assessments

6 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Labetalol
  • Nifedipine
Trial Overview The study compares the effects of starting antihypertensive drugs (Labetalol or Nifedipine) right after childbirth versus standard care on reducing high blood pressure and related health issues in women with recent preeclampsia.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol or nifedipine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects.
Group II: No-treatmentActive Control1 Intervention

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

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Labetalol for:
  • Hypertension
  • Preeclampsia
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Labetalol for:
  • Hypertension
  • Preeclampsia
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Labetalol for:
  • Hypertension
  • Preeclampsia
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Labetalol for:
  • Hypertension

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Findings from Research

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

References

Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial. [2022]
IV labetalol and oral nifedipine in acute control of severe hypertension in pregnancy-A randomized controlled trial. [2019]
Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. [2022]
Short-term treatment of severe hypertension of pregnancy: prospective comparison of nicardipine and labetalol. [2013]
The optimal treatment of severe hypertension in pregnancy: update of the role of nicardipine. [2019]
Antihypertensive drugs in pregnancy. [2011]
Nifedipine versus labetalol in the treatment of hypertensive disorders of pregnancy. [2013]
Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial. [2023]
Comparing the efficacy of oral labetalol with oral amlodipine in achieving blood pressure control in women with postpartum hypertension: randomized controlled trial (HIPPO study-Hypertension In Pregnancy & Postpartum Oral-antihypertensive therapy). [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Committee Opinion No. 692 Summary: Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy and the Postpartum Period. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
ACOG Committee Opinion No. 767 Summary: Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy and the Postpartum Period. [2019]
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