Recruiting
Phase 1

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05989581

Conditions

Hypertension in Pregnancy

Eligibility Criteria

Sex: Female

Age: 14 - 70+

Healthy Volunteers: Accepted

Interventions

Labetalol or Nifedipine

Study Details

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 ID

NCT05989581

Start date

Apr 24, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BP goal <130/80mmHg

no intervention: BP goal <140/90 (usual care)

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.

Primary outcome measure

  • Neonatal Birthweight percentile [ Time Frame: at delivery of infant ]

Central Contacts and Locations

Central contacts

Donna Dunn, PhD

12058739503dcampbell@uabmc.edu

Jhana Plump

jplump@uabmc.edu

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Donna Campbell

(205) 996-6268dcampbell@uabmc.edu

Victoria Jauk

334-477-1740vchapman@uab.edu

Principal Investigator:

Rachel Sinkey, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 11, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-11.