Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Labetalol; Nifedipine

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