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Recruiting Phase 1 NCT05989581

Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

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Trial Parameters

Condition Hypertension in Pregnancy
Sponsor University of Alabama at Birmingham
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 74
Sex FEMALE
Min Age 14 Years
Max Age 89 Years
Start Date 2024-04-24
Completion 2026-04-30
Interventions
Labetalol or Nifedipine

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Brief Summary

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.

Eligibility Criteria

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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