Study Details

Purpose

The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant adults (<140/90 mmHg) is effective and safe

Condition Intervention Phase
Hypertension Other: Anti-hypertensive therapy
Other: No to low dose anti-hypertensive therapy
Phase 4
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pragmatic Multicenter RCT of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project

Primary Outcome Measures:

  • Composite adverse perinatal outcome [Time Frame: Up to 3 months after delivery] [Designated as safety issue: No]
    One of more severe outcomes including fetal or neonatal death up to 3 months; preeclampsia with severe features (by ACOG) definition); placental abruption; or indicated PT <35 weeks (not due to spontaneous preterm labor or membrane rupture)
  • Small for Gestational Age [Time Frame: Until delivery] [Designated as safety issue: Yes]
    Birth weight less than 10th percentile for gestational age at birth according to accepted national standard

Secondary Outcome Measures:

  • Composite of maternal death or severe cardiovascular morbidity [Time Frame: Up to 3 months after delivery] [Designated as safety issue: No]
    One or more of maternal death, heart failure, stroke, encephalopathy, Myocardial infarction or ischemia, pulmonary edema, ICU admission or renal failure
  • Composite of severe adverse perinatal outcome [Time Frame: Up to 12 weeks after delivery] [Designated as safety issue: No]
    One or more of perinatal death, IVH III or IV, BPD or chronic lung disease, NEC, ROP, Seizures, Proven sepsis
  • Adherence to treatment after delivery [Time Frame: Up to 12 weeks after delivery ] [ Designated as safety issue: No ]
    Adherence to antihypertensive therapy after delivery

Other Outcome Measures:

  • Preeclampsia [ Time Frame: Up to 1 week after delivery ] [ Designated as safety issue: No ]
    Mild or severe, including eclampsia
  • Superimposed gestational hypertension [ Time Frame: Up to one week after delivery ] [ Designated as safety issue: No ]
    Persistent hypertension above baseline without proteinuria occurring after 20 weeks gestation
  • Maternal systolic and diastolic blood pressure [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Mean change in serial blood pressure values pregnancy
  • Severe hypertension [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Blood pressure ≥160/110
  • Cesarean delivery [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Cesarean delivery
  • Preterm birth [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Delivery at <37 weeks
  • NICU admission [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    NICU admission and length of NICU stay
  • Low birth weight [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Birth weight <2500g
  • Ponderal index [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Mean ponderal index
  • Head circumference [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Mean head circumference
  • Placental weight [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Mean placental weight
  • Hypoglycemia [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Prevalence of hypoglycemia
  • Bradycardia [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Prevalence of bradycardia
  • Hypotension [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with hypotension
  • Respiratory distress syndrome (RDS) [ Time Frame: Up to 1 week after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with RDS
  • Bronchopulmonary dysplasia (BPD) [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with BPD
  • Intubation/ventilation [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with intubation for ventilation
  • Intraventricular hemorrhage (IVH) [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with any IVH and with IVH Grades III and IV
  • Necrotizing enterocolitis (NEC) [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with NEC
  • Hyperbilirubinemia [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with hyperbilirubinemia
  • 5-min Apgar score [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Apgar score <7
  • Sepsis [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Incidence (%) with sepsis
  • Unscheduled prenatal clinic or ER visits [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Number of unscheduled clinic or ER visits before and after delivery
  • Hospitalizations [ Time Frame: Up to 3 months postpartum ] [ Designated as safety issue: No ]
    Number of hospitalizations before or after delivery
  • Postpartum unscheduled or ER visits [ Time Frame: Up to 3 months after delivery ] [ Designated as safety issue: No ]
    Number of postpartum unscheduled or ER visits
  • Postpartum hospitalizations [Time Frame: Up to 3 months after delivery ][ Designated as safety issue: No ]
    Number of postpartum hospitalizations
Estimated Enrollment: 4700
Study Start Date: August 2015
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)