Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Description

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.

Conditions

Hypertension in Pregnancy

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Study Overview

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Study Details

Study overview

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.

Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial

Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Condition
Hypertension in Pregnancy
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

14 Years to 89 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Alabama at Birmingham,

Study Record Dates

2025-06-30