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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 14
Maximum Age: 89
Healthy Volunteers: t
View:

• 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

Locations
United States
Alabama
UAB
RECRUITING
Birmingham
Contact Information
Primary
Donna Dunn, PhD
dcampbell@uabmc.edu
12058739503
Backup
Jhana Plump
jplump@uabmc.edu
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 74
Treatments
Experimental: BP goal <130/80mmHg
No_intervention: BP goal <140/90 (usual care)
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov