NCT05989581PHASE1RecruitingAccepts Healthy Volunteers

Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

University of Alabama at Birmingham

Start Date

4/24/2024

Completion Date

12/31/2026

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

Age Range: 14 years to 89 years

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

Interventions

DRUG

Labetalol or Nifedipine

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Conditions

Hypertension in Pregnancy

Locations

UAB

Birmingham, Alabama 35294

United States