Antihypertensive Treatment for Postpartum Hypertension (P-PAT Trial)
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Medical College of Wisconsin
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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.
Is the drug Labetalol, Nifedipine a promising treatment for postpartum hypertension?Yes, Labetalol and Nifedipine are promising drugs for treating postpartum hypertension. Studies show that both can effectively manage high blood pressure after childbirth. Labetalol is often used as a first-choice treatment, while Nifedipine is also considered effective, especially when intravenous access is not available.5681011
What safety data exists for antihypertensive treatments like labetalol and nifedipine in postpartum hypertension?Existing safety data for labetalol and nifedipine, used in treating hypertension during pregnancy, indicate that both medications are considered safe for use. Studies have compared their efficacy and safety in managing severe hypertension in pregnancy, showing that they are effective in controlling blood pressure with manageable side effects. These medications are recommended for use in pregnancy, while others like ACE inhibitors should be avoided. The management of postpartum hypertension and safe use during lactation are also discussed in the literature.12349
What data supports the idea that Antihypertensive Treatment for Postpartum Hypertension is an effective drug?The available research shows that both labetalol and nifedipine are effective in controlling blood pressure in women with postpartum hypertension. One study found that labetalol and nifedipine were equally effective in managing blood pressure in pregnant women with chronic hypertension, with similar average blood pressure readings. Another study compared oral labetalol to oral nifedipine for postpartum hypertension and aimed to determine which drug led to faster blood pressure control. These studies suggest that both drugs are effective options for treating postpartum hypertension.14579
Do I need to stop my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
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
I was diagnosed with preeclampsia during or right after my pregnancy.
I am 18 years old or older.
Exclusion Criteria
I was diagnosed with preeclampsia after leaving the hospital from giving birth.
I started blood pressure medication after giving birth due to high readings.
I have long-term high blood pressure and now also have preeclampsia.
Treatment Details
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.
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:
🇪🇺 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Medical College of Wisconsin-Froedtert HospitalMilwaukee, WI
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
References
Short-term treatment of severe hypertension of pregnancy: prospective comparison of nicardipine and labetalol. [2013]To assess the efficacy and safety of nicardipine in comparison to labetalol in the initial management of severe hypertension in pregnancy. DESIGN. Randomized prospective study.
Antihypertensive drugs in pregnancy. [2011]Blood pressure targets and medications that are safe differ in pregnant women compared with nonpregnant individuals. The principles of treatment for mild, moderate, and severe hypertension in pregnancy, chronic versus gestational versus preeclampsia, and women hypertensive at term versus remote from term are reviewed. The choice of antihypertensive drugs also is discussed; methyldopa, labetalol, and nifedipine, among others, appear safe for use in pregnancy, whereas angiotensin converting enzyme inhibitors and angiotensin receptor blockers should be avoided. The management of increased blood pressure in the postpartum period, and agents to use in lactation, are also discussed.
Nifedipine versus labetalol in the treatment of hypertensive disorders of pregnancy. [2013]To assess the maternal and fetal outcomes of pregnancies affected by hypertensive disorders treated with nifedipine versus labetalol.
The optimal treatment of severe hypertension in pregnancy: update of the role of nicardipine. [2019]Hypertensive disorders in pregnancy remain a major cause of maternal morbidity and mortality. Blood pressure control is essential for maternal and neonatal outcome. Therefore, we analyzed the potency and side effects of two treatment options (nicardipine compared to labetalol) in order to gain insight in improved treatment of severe hypertension during pregnancy and to evaluate the feasibility of a randomised controlled trial.
Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. [2022]To determine whether oral labetalol is associated with a shorter time to blood pressure control compared to oral extended release nifedipine for management of persistent postpartum hypertension.
Committee Opinion No. 692 Summary: Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy and the Postpartum Period. [2018]Acute-onset, severe systolic hypertension; severe diastolic hypertension; or both can occur during the prenatal, intrapartum, or postpartum periods. Pregnant women or women in the postpartum period with acute-onset, severe systolic hypertension; severe diastolic hypertension; or both require urgent antihypertensive therapy. Introducing standardized, evidence-based clinical guidelines for the management of patients with preeclampsia and eclampsia has been demonstrated to reduce the incidence of adverse maternal outcomes. Individuals and institutions should have mechanisms in place to initiate the prompt administration of medication when a patient presents with a hypertensive emergency. Treatment with first-line agents should be expeditious and occur as soon as possible within 30-60 minutes of confirmed severe hypertension to reduce the risk of maternal stroke. Intravenous labetalol and hydralazine have long been considered first-line medications for the management of acute-onset, severe hypertension in pregnant women and women in the postpartum period. Although relatively less information currently exists for the use of calcium channel blockers for this clinical indication, the available evidence suggests that immediate release oral nifedipine also may be considered as a first-line therapy, particularly when intravenous access is not available. In the rare circumstance that intravenous bolus labetalol, hydralazine, or immediate release oral nifedipine fails to relieve acute-onset, severe hypertension and is given in successive appropriate doses, emergent consultation with an anesthesiologist, maternal-fetal medicine subspecialist, or critical care subspecialist to discuss second-line intervention is recommended.
Labetalol Versus Nifedipine as Antihypertensive Treatment for Chronic Hypertension in Pregnancy: A Randomized Controlled Trial. [2022]Data from randomized controlled trials to guide antihypertensive agent choice for chronic hypertension in pregnancy are limited; this study aimed to compare labetalol and nifedipine, additionally assessing the impact of ethnicity on treatment efficacy. Pregnant women with chronic hypertension (12+0-27+6 weeks' gestation) were enrolled at 4 UK centers (August 2014 to October 2015). Open-label first-line antihypertensive treatment was randomly assigned: labetalol- (200-1800 mg/d) or nifedipine-modified release (20-80 mg/d). Analysis included 112 women (98%) who completed the study (labetalol n=55, nifedipine n=57). Maximum blood pressure after randomization was 161/101 mm Hg with labetalol versus 163/105 mm Hg with nifedipine (mean difference systolic: 1.2 mm Hg [-4.9 to 7.2 mm Hg], diastolic: 3.3 mm Hg [-0.6 to 7.3 mm Hg]). Mean blood pressure was 134/84 mm Hg with labetalol and 134/85 mm Hg with nifedipine (mean difference systolic: 0.3 mm Hg [-2.8 to 3.4 mm Hg], and diastolic: -1.9 mm Hg [-4.1 to 0.3 mm Hg]). Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis. No difference in treatment effect was observed in black women (n=63), but a mean 4 mm Hg reduction (-6.6 to -0.8 mm Hg; P=0.015) in brachial diastolic blood pressure was observed with labetalol compared with nifedipine in non-black women (n=49). Labetalol and nifedipine control mean blood pressure to target in pregnant women with chronic hypertension. This study provides support for a larger definitive trial scrutinizing the benefits and side effects of first-line antihypertensive treatment.
ACOG Committee Opinion No. 767 Summary: Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy and the Postpartum Period. [2019]Acute-onset, severe systolic hypertension; severe diastolic hypertension; or both can occur during the prenatal, intrapartum, or postpartum periods. Pregnant women or women in the postpartum period with acute-onset, severe systolic hypertension; severe diastolic hypertension; or both require urgent antihypertensive therapy. Introducing standardized, evidence-based clinical guidelines for the management of patients with preeclampsia and eclampsia has been demonstrated to reduce the incidence of adverse maternal outcomes. Individuals and institutions should have mechanisms in place to initiate the prompt administration of medication when a patient presents with a hypertensive emergency. Treatment with first-line agents should be expeditious and occur as soon as possible within 30-60 minutes of confirmed severe hypertension to reduce the risk of maternal stroke. Intravenous labetalol and hydralazine have long been considered first-line medications for the management of acute-onset, severe hypertension in pregnant women and women in the postpartum period. Although relatively less information currently exists for the use of calcium channel blockers for this clinical indication, the available evidence suggests that immediate release oral nifedipine also may be considered as a first-line therapy, particularly when intravenous access is not available. In the rare circumstance that intravenous bolus labetalol, hydralazine, or immediate release oral nifedipine fails to relieve acute-onset, severe hypertension and is given in successive appropriate doses, emergent consultation with an anesthesiologist, maternal-fetal medicine subspecialist, or critical care subspecialist to discuss second-line intervention is recommended.
IV labetalol and oral nifedipine in acute control of severe hypertension in pregnancy-A randomized controlled trial. [2019]To compare the efficacy of intravenous labetalol with oral nifedipine in the treatment of severe hypertension in pregnancy with blood pressure ≥160/110 mm Hg.
Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial. [2023]To compare the efficacy of oral Labetalol versus oral Nifedipine for the treatment of postpartum hypertension.
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]De novo - or as a continuum of antenatal hypertension -postpartum hypertension complicates ~2% of pregnancies. Many maternal complications, such as eclampsia and cerebrovascular accidents, occur in the postpartum period. Despite widespread use of antihypertensives during pregnancy and childbirth, there is a paucity of data on preferred medications in the postpartum period. This randomized controlled study enrolled 130 women who were started on antihypertensives. They were randomized to receive oral Labetalol(LAB, maximum 900 mg per day in three doses) or oral Amlodipine(AML, maximum 10 mg per day given in two doses). In the immediate postpartum, all women were closely monitored for neurological symptoms, blood pressure, heart rate, respiratory rate, urine output, and deep tendon reflex. The primary outcome was the time to achieve sustained blood pressure control for 12 h from the initiation of medication; secondary outcomes included side effects of both medications. Mean time to achieve sustained blood pressure control was lower in women who received AML than in those who received LAB-(mean difference 7.2 h; 38 95% CI 1.4, 12.9, p = 0.011). There were fewer severe hypertensive episodes among those with AML than in those who received LAB. However, the proportion of women who continued to require antihypertensives at discharge was higher in the AML group than in the LAB group (55.4% versus 32.3%, p = 0.008). None of the participants developed drug-related side effects. Among women with postpartum persistence or new-onset hypertension, oral AML achieved sustained blood pressure control in a shorter duration, with fewer hypertensive emergencies than oral LAB. (CTRI/2020/02/023236).Trial Registration details: The study protocol was registered with Clinical Trial Registry of India with CTRI Number CTRI/2020/02/023236 dated 11.02.2020. Protocol can be accessed at https://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=40435&EncHid=&modid=&compid=%27,%2740435det%27 .