Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Hypertension in Pregnancy Clinical Trial

— CHAP2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989581
• Other study ID #: 3000010726
• Status: Recruiting
• Phase: Phase 1
• Start date: April 24, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Donna Dunn, PhD
• Phone: 12058739503
• Email: dcampbell[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Intervention

Drug:
• Labetalol or Nifedipine
The choice of anti-HTN will be based on the patient and provider's experience and preference. First line anti-HTN recommended in pregnancy- labetalol or nifedipine- will be administered to patients. At least weekly, a study team member will review the participants' BPs and, if randomized to intervention and a higher dose is needed to maintain BPs <130/80 mmHg, the study team member will communicate with the clinical team, led by a University of Alabama Maternal Fetal Medicine Attending, in order to ensure coordination between the research and clinical care teams. Labetalol will be initiated at 200 mg twice daily and escalated in 200mg /dose daily until BP<130/80mmHg to a maximum dose of 2400mg/day. Procardia will be initiated at 30mg XL once daily and uptitrated in 30mg increments until a maximum dose of 120mg daily. Postpartum, titration will occur in similar fashion. The patient will be transitioned to her primary care provider for BP management after the 6-week postpartum visit.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Birthweight percentile	To determine whether anti-HTN treatment to BP<130/80mmHg in pregnant patients with Stage 1 HTN is associated with a difference in birthweight percentile at delivery	at delivery of infant