NCT05309460 · Nebraska Methodist Health System
Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
What this study is about
randomly assigned trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.
View original scientific description
Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.
Interventions
DRUG
Labetalol Oral Tablet
See Labetalol arm.
DRUG
NIFEdipine ER
See Nifedipine arm.
Primary outcome measures
Readmission
Time frame: 6 months
Patients will be monitored following delivery for readmission to the hospital. To improve patient capture, all patients will be called at 6 months to identify complications or if hospital admission occured in the 6 months following delivery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Any patient admitted for delivery by cesarean or vaginal delivery at 24 weeks gestation or greater with hypertension(HTN). Hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN. Following enrollment, treatment will be escalated at discretion of primary provider with the goal of normotension.
Exclusion criteria
- History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema
- Contraindication to either Nifedipine or Labetalol
- HR \<60 or \>110
- Native language other than English or Spanish
Where
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 12, 2024 · Source of record for eligibility and locations