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) |