Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project (CHAP2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension in Pregnancy
• Intervention / Treatment: Drug: Labetalol or Nifedipine

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Donna Dunn, PhD; Phone Number: 12058739503; Email: dcampbell@uabmc.edu
• Study Contact Backup: Name: Jhana Plump; Email: jplump@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • UAB
      • Contact: Victoria Jauk; Phone Number: 334-477-1740; Email: vchapman@uab.edu
      • Contact: Donna Campbell; Phone Number: (205) 996-6268; Email: dcampbell@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BP goal <130/80mmHg	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.
No Intervention: BP goal <140/90 (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal blood pressure	Systolic and diastolic blood pressure	prenatal, delivery, postpartum up to 6 weeks after delivery
Gestational age at delivery	Gestational age at delivery, preterm birth <37 weeks' gestation, preterm birth<34 weeks' gestation	prenatal, delivery, postpartum up to 6 weeks after delivery
Maternal adverse cardiovascular composite	Heart failure, stroke, myocardial infarction or angina, pulmonary edema, ICU admission, encephalopathy, renal failure, death	prenatal, delivery, postpartum up to 6 weeks after delivery
Incidence of Hypertensive disorders of pregnancy	Preeclampsia, eclampsia, gestational hypertension	prenatal, delivery, postpartum up to 6 weeks after delivery

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amides; Amines; Alcohols; Amino Alcohols; Ethanolamines; Dihydropyridines; Salicylamides; Nifedipine; Labetalol
• Other Study ID Numbers: 3000010726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No