drugset / Trial / NCT05989581

Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

NCT05989581

Phase 1 Recruiting 74 enrolled University of Alabama at Birmingham
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-04-24
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Labetalol Small molecule 2400 mg
Subject Nifedipine Other / unclassified 120 mg