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Blood Pressure Medication for Pregnant Women with Hypertension (CHAP2 Trial)

Phase 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Comorbidities requiring BP goals < 130/80mmHg
Declines Randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prenatal, delivery, postpartum up to 6 weeks after delivery
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study whether treating mild high blood pressure in pregnant women can improve the health of both the mother and the baby. They will compare birth weights of babies born to mothers who received treatment for

Who is the study for?
This trial is for pregnant individuals planning to deliver at UAB Hospital, with a healthy single baby and no fetal anomalies. They should have mild high blood pressure (130-139/80-89mmHg) recorded twice before 20 weeks of pregnancy and be receiving care at UAB prenatal clinics.
What is being tested?
The CHAP2 study tests if treating stage 1 hypertension in pregnancy with Labetalol or Nifedipine to lower blood pressure below 130/80mmHg improves birthweight outcomes. Participants are randomly assigned to either active treatment or usual care where treatment starts only if BP rises above 140/90mmHg.
What are the potential side effects?
Possible side effects from Labetalol may include fatigue, dizziness, or nausea; while Nifedipine can cause swelling in the legs, flushing, or heart palpitations. Side effects vary by individual.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have health conditions that require my blood pressure to be below 130/80 mmHg.
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I choose not to be randomly assigned to a treatment group.
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I have known genetic abnormalities.
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I have high blood pressure or am taking medication for it.
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I cannot take certain blood pressure medicines like Nifedipine or Labetalol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prenatal, delivery, postpartum up to 6 weeks after delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and prenatal, delivery, postpartum up to 6 weeks after delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neonatal Birthweight percentile
Secondary study objectives
Gestational age at delivery
Incidence of Hypertensive disorders of pregnancy
Maternal adverse cardiovascular composite
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BP goal <130/80mmHgExperimental Treatment1 Intervention
Group II: BP goal <140/90 (usual care)Active Control1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,640 Previous Clinical Trials
2,332,016 Total Patients Enrolled
49 Trials studying Hypertension
93,251 Patients Enrolled for Hypertension
~31 spots leftby Apr 2025
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