Your session is about to expire
← Back to Search
Beta Blocker
Blood Pressure Medication for Early Pregnancy Hypertension
Phase 2
Waitlist Available
Research Sponsored by Marshall University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Patients with end stage renal disease
Patients with the diagnosis of chronic hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether treating high blood pressure in early pregnancy with specific medications (nifedipine or labetalol) improves health outcomes for mothers and babies. The study focuses on pregnant women with elevated blood pressure. These medications work by relaxing blood vessels or slowing the heart rate to lower blood pressure. Nifedipine and labetalol are commonly used medications for high blood pressure in pregnancy, with studies showing their effectiveness in managing hypertensive disorders of pregnancy.
Who is the study for?
This trial is for pregnant individuals between 12 and 16 weeks gestation, under care at Marshall University offices, with slightly elevated blood pressure (systolic 120-139 or diastolic 80-89). It's not for those already on hypertension medication, with chronic hypertension, substance use disorders, alcohol consumption during pregnancy, diabetes or end stage renal disease.
What is being tested?
The study compares the effects of treating early pregnancy high blood pressure with either Labetalol or Nifedipine versus no treatment. Participants will be randomly assigned to one of these three groups after giving their consent.
What are the potential side effects?
Labetalol may cause fatigue, headache, dizziness or nausea. Nifedipine can lead to swelling in the legs and feet, flushing, heart palpitations and may occasionally lower your blood pressure too much.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidneys are in the final stage of failure.
Select...
I have been diagnosed with chronic high blood pressure.
Select...
My blood pressure is 140/90 or higher, indicating chronic hypertension.
Select...
I am currently taking medication for high blood pressure.
Select...
I have Type I or Type II Diabetes Mellitus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment of elevated blood pressures
Secondary study objectives
ICG directed treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Treatment GroupActive Control2 Interventions
Treatment of elevated blood pressures (120 or greater systolic OR 80 or greater diastolic)
Group II: Non-treatment GroupActive Control1 Intervention
Non-treatment of blood pressures between 120-139 systolic and 80-89 diastolic
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, and diuretics. ACE inhibitors and ARBs work by relaxing blood vessels through the inhibition of angiotensin-converting enzyme and blocking angiotensin II receptors, respectively, which reduces blood pressure.
Calcium channel blockers prevent calcium from entering the heart and blood vessel walls, leading to relaxed vessels and lower blood pressure. Diuretics help the kidneys remove excess sodium and water from the body, decreasing blood volume and pressure.
These mechanisms are crucial for high blood pressure patients as they help prevent complications such as stroke, heart attack, and kidney damage by effectively lowering and managing blood pressure levels.
Implications of the links between hypertension and myocardial infarction for choice of drug therapy in patients with hypertension.Prehypertension: the rationale for early drug therapy.Recent hypertension trials: implications and controversies.
Implications of the links between hypertension and myocardial infarction for choice of drug therapy in patients with hypertension.Prehypertension: the rationale for early drug therapy.Recent hypertension trials: implications and controversies.
Find a Location
Who is running the clinical trial?
Marshall UniversityLead Sponsor
20 Previous Clinical Trials
3,928 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys are in the final stage of failure.I have been diagnosed with chronic high blood pressure.My blood pressure is 140/90 or higher, indicating chronic hypertension.I agree to be randomly assigned to a treatment group after giving my consent.I am currently taking medication for high blood pressure.You are currently drinking alcohol while pregnant.I have Type I or Type II Diabetes Mellitus.You are currently using illegal drugs or have had problems with drug or alcohol abuse in the past.Your blood pressure should be between 120-139 over 80-89.You are either less than 12 weeks pregnant or more than 16 weeks pregnant.Pregnant patients at Marshall University with high blood pressure readings between 12 and 16 weeks of pregnancy will not be included.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Non-treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.