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Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

RECRUITINGPhase 1Sponsored by University of Alabama at Birmingham
Actively Recruiting
PhasePhase 1
SponsorUniversity of Alabama at Birmingham
Started2024-04-24
Est. completion2026-04-30
Eligibility
Age14 Years – 89 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site

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

Age: 14 Years – 89 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

Heart DiseaseHypertension in Pregnancy

Locations1 site

UAB
Birmingham, Alabama, 35294
Donna Campbell(205) 996-6268dcampbell@uabmc.edu

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