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: | 2404 |
| Study Start Date: | August 2015 |
| Estimated Study Completion Date: | March 2021 |
| Estimated Primary Completion Date: | November 2021 (Final data collection date for primary outcome measure) |