Nifedipine vs Labetalol for Postpartum Hypertension (SCARPH Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Loma Linda University
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.
12345Is 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.
12456What 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.
12567Eligibility 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
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.
I have a history of asthma, heart disease, or fluid in my lungs.
I cannot take Nifedipine or Labetalol due to adverse reactions.
Participant Groups
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.
2Treatment groups
Active Control
Group I: Oral NifedipineActive Control1 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 LabetalolActive Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Loma Linda University HealthLoma Linda, CA
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
References
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.
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 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.
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.
A trial of oral nifedipine and oral labetalol in preeclampsia hypertensive emergency treatment. [2018]This observational retrospective cohort study was conducted to compare oral nifedipine and labetalol for emergency treatment of hypertension in preeclamptic patients. Time (minutes) and necessary doses were outlined to achieve blood pressure lower than 150/95 mmHg. In 14 patients with preeclampsia, 55 hypertensive emergencies were identified (BP >150/95). Of these emergencies, 43 were treated with oral nifedipine 10 mg (10 patients) and 12 with oral labetalol 100 mg (4 patients). To achieve a target blood pressure under 150/95, these doses were repeated as necessary every 20 min, up to a maximum of 4 doses. Oral nifedipine reduced BP more rapidly (31.30 vs. 53.50 min, p = .03). No maternal or foetal adverse events were observed and no major differences were found according to the type of delivery. Oral nifedipine is faster than and at least as safe as labetalol in pre-eclampsia hypertensive emergency treatment.
Oral nifedipine versus intravenous labetalol for severe hypertension during pregnancy: a systematic review and meta-analysis. [2022]Oral nifedipine is recommended along with labetalol and hydralazine for treatment of severe hypertension during pregnancy by most authorities. Although nifedipine is cheap and easily administered, the usage pattern among health care providers suggests a strong preference for labetalol despite lack of evidence for the same.
Oral nifedipine may be a preferential option for treating acute severe hypertension during pregnancy: a meta-analysis. [2023]To compare oral nifedipine and intravenous labetalol in the treatment of acute severe hypertension in pregnancy (SHP).