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NCT Number: NCT05989581

Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

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.

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

14 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Neonatal Birthweight percentile

    Time frame: at delivery of infant

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Donna Dunn, PhD

CONTACT

[email protected]

12058739503

Jhana Plump

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: CHAP2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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