Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

The University of Alabama at Birmingham

Status and phase

Enrolling

Phase 1

Conditions

Hypertension in Pregnancy

Treatments

Drug: Labetalol or Nifedipine

Study type

Interventional

Funder types

Other

Identifiers

NCT05989581

3000010726

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

Female

Ages

14 to 89 years old

Volunteers

Accepts Healthy Volunteers

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