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Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

RecruitingPhase 1Ages 14 Years - 89 YearsFemaleUniversity of Alabama at Birmingham
NCT05989581 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Viable singleton gestation * No fetal anomalies * Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation * Planning to deliver at UAB Hospital * No indication for pregnancy termination * Receiving care at the UAB prenatal clinics Exclusion Criteria: * Declines Randomization * Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive medication use * Fetal demise diagnosed prior to enrollment * Known major structural of chromosomal abnormalities prior to enrollment * Contraindication to first line antihypertensive (Nifedipine/ Labetalol) * Comorbidities requiring BP goals \< 130/80mmHg
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What it tests

  • Labetalol or Nifedipine
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Where

1 site
UAB
Birmingham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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