Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05989581
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hypertension in Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 89 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Apr 24, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BP goal <130/80mmHg
  • No Intervention: BP goal <140/90 (usual care)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UABBirminghamAlabama35294
Donna Campbell
[email protected]
(205) 996-6268
Victoria Jauk
[email protected]
334-477-1740

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By research site
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