Actively Recruiting
Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial
Led by University of Alabama at Birmingham · Updated on 2026-04-09
74
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether treating stage 1 hypertension in pregnant patients can improve outcomes for both mother and baby. This pilot study aims to see if controlling blood pressure to below 130/80 mmHg affects the baby's birthweight percentile at delivery. A total of 74 pregnant individuals with stage 1 hypertension will be included to gather preliminary data for a larger future study. Participants will be randomly assigned to one of two groups: an active treatment group targeting blood pressure below 130/80 mmHg, or a usual care group treated only if blood pressure reaches 140/90 mmHg or higher. The treatments studied include labetalol or nifedipine, commonly used blood pressure medications during pregnancy. These medications will be started and adjusted weekly to reach the blood pressure goals. After delivery and a 6-week postpartum visit, participants will transition to their primary care provider for ongoing blood pressure management. Throughout the study, participants will have their blood pressure monitored at least weekly by the study team who will coordinate with clinical care providers. The main outcome measured is the baby's birthweight percentile at delivery. Participants will be involved from early pregnancy until 6 weeks after birth, with ongoing assessments to ensure treatment coordination and safety. This will help determine if tighter blood pressure control benefits maternal and neonatal health during pregnancy.
CONDITIONS
Brief Title
Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Viable singleton pregnancy
- No fetal anomalies
- Blood pressures between 130-139/80-89 mmHg on two occasions at least 4 hours apart before 20 weeks gestation
- Planning to deliver at the University of Alabama at Birmingham Hospital
- No indication for pregnancy termination
- Receiving prenatal care at UAB clinics
You will not qualify if you...
- Declines randomization
- Known chronic hypertension with blood pressure 140/90 mmHg or higher or current antihypertensive medication use
- Fetal demise diagnosed before enrollment
- Known major structural or chromosomal abnormalities before enrollment
- Contraindication to first-line antihypertensive medications (nifedipine or labetalol)
- Comorbid conditions requiring blood pressure goals below 130/80 mmHg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment through 6 weeks postpartum
Participants receive antihypertensive medication with labetalol or nifedipine to manage blood pressure during pregnancy, with doses adjusted at least weekly to maintain target blood pressure levels.
At least weekly visits for blood pressure review and medication adjustment
Trial Site Locations
Total: 1 location
1
UAB
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
D
Donna Dunn, PhD
J
Jhana Plump
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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