Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

NCT ID: NCT05989581

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Hypertension in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BP goal <130/80mmHg

Group Type: EXPERIMENTAL

Labetalol or Nifedipine

Intervention Type: DRUG

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.

BP goal <140/90 (usual care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ayodeji Sanusi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UAB

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Donna Dunn, PhD

Role: CONTACT

dcampbell@uabmc.edu

12058739503

Jhana Plump

Role: CONTACT

jplump@uabmc.edu

Facility Contacts

Donna Campbell

Role: primary

dcampbell@uabmc.edu

(205) 996-6268

Victoria Jauk

Role: backup

vchapman@uab.edu

334-477-1740

Other Identifiers

3000010726

Identifier Type: -

Identifier Source: org_study_id