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Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project (CHAP2)

Primary Purpose

Hypertension in Pregnancy

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BP <130/80mmHg
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension in Pregnancy

Eligibility Criteria

14 Years - 89 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    BP goal <130/80mmHg

    BP goal <140/90 (usual care)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Neonatal Birthweight percentile
    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

    Secondary Outcome Measures

    Maternal blood pressure
    Systolic and diastolic blood pressure
    Gestational age at delivery
    Gestational age at delivery, preterm birth <37 weeks' gestation, preterm birth<34 weeks' gestation
    Hypertensive disorders of pregnancy
    Preeclampsia, eclampsia, gestational hypertension
    Maternal adverse cardiovascular composite
    Heart failure, stroke, myocardial infarction or angina, pulmonary edema, ICU admission, encephalopathy, renal failure, death

    Full Information

    First Posted
    July 26, 2023
    Last Updated
    August 4, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05989581
    Brief Title
    Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
    Acronym
    CHAP2
    Official Title
    Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 18, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 improve 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, we will randomize a total of 74 eligible participants, 37 to active treatment to BP<130/80mmHg and 37 to usual care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension in Pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    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, we will randomize a total of 74 eligible participants, 37 to active treatment to BP<130/80mmHg and 37 to usual care.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    74 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BP goal <130/80mmHg
    Arm Type
    Experimental
    Arm Title
    BP goal <140/90 (usual care)
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    BP <130/80mmHg
    Intervention Description
    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 Information:
    Title
    Neonatal Birthweight percentile
    Description
    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
    Time Frame
    at delivery of infant
    Secondary Outcome Measure Information:
    Title
    Maternal blood pressure
    Description
    Systolic and diastolic blood pressure
    Time Frame
    prenatal, delivery, postpartum up to 6 weeks after delivery
    Title
    Gestational age at delivery
    Description
    Gestational age at delivery, preterm birth <37 weeks' gestation, preterm birth<34 weeks' gestation
    Time Frame
    prenatal, delivery, postpartum up to 6 weeks after delivery
    Title
    Hypertensive disorders of pregnancy
    Description
    Preeclampsia, eclampsia, gestational hypertension
    Time Frame
    prenatal, delivery, postpartum up to 6 weeks after delivery
    Title
    Maternal adverse cardiovascular composite
    Description
    Heart failure, stroke, myocardial infarction or angina, pulmonary edema, ICU admission, encephalopathy, renal failure, death
    Time Frame
    prenatal, delivery, postpartum up to 6 weeks after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Donna Dunn, PhD
    Phone
    12058739503
    Email
    dcampbell@uabmc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jhana Plump
    Email
    jplump@uabmc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

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