Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Phase 1

Recruiting

• Conditions: Hypertension in Pregnancy
• Interventions: Drug: Labetalol or Nifedipine

• Registration Number: NCT05989581
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Status Verified: 2024-04
• Study Start: 2024-04-24
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BP goal <130/80mmHg	Labetalol or Nifedipine	-

Primary Outcome Measures

Name	Time	Method
Neonatal Birthweight percentile	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

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States