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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 14 Years and 89 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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 74 eligible participants, 37 to active treatment to BP<130/80mmHg and 37 to usual care.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

UAB
Birmingham, Alabama 35294
Contact:
Donna Campbell
205-996-6268
dcampbell@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Donna Dunn, PhD
12058739503
dcampbell@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.