Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

NCT05989581 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 3000010726
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

BP goal <130/80mmHg

EXPERIMENTAL

Drug: Labetalol or Nifedipine

BP goal <140/90 (usual care)

NO INTERVENTION

Interventions

Labetalol or Nifedipine 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 <130/80mmHg

Eligibility Criteria

• Age: 14 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Labetalol; Nifedipine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Donna Dunn, PhD

CONTACT

12058739503; dcampbell@uabmc.edu

Jhana Plump

CONTACT

jplump@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with stage 1 HTN 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 146 eligible participants, 73 to active treatment to BP\<130/80mmHg and 73 to usual care.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: April 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)