Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Phase

Condition

Stress

High Blood Pressure (Hypertension - Pediatric)

Vascular Diseases

Treatment

Labetalol or Nifedipine

BP <130/80mmHg

Clinical Study ID

NCT05989581

3000010726

Ages 14-89
Female
Accepts Healthy Volunteers

Study 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

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

Exclusion Criteria:

Declines Randomization
Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or currentantihypertensive 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

Study Design