Hypertension, Pregnancy-Induced
Conditions
Brief summary
The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.
Detailed description
The REPAIR trial is a multicenter randomized controlled trial of 618 postpartum patients with hypertensive disorders of pregnancy randomized to intensive blood pressure control versus usual care during the first 6 weeks postpartum. The intervention group will receive intensive blood pressure (BP) control with nifedipine extended-release initiation when BP is ≥ 140/90 mmHg. The active control group will receive usual care with nifedipine ER initiation when BP is ≥ 150/100. The study will take place at two clinical sites: Medical College of Wisconsin (MCW) and Northwestern University (NU). All participants will undergo BP monitoring, cardiovascular function assessment, and collection of cardiovascular biomarkers at baseline, 6 weeks, and 12 months postpartum. Specifically, cardiac function and structure will be assessed with transthoracic echocardiogram, endothelial dysfunction with brachial artery flow-mediated dilation, and arterial stiffness with carotid-femoral pulse wave velocity. The primary outcome is the incident diagnosis of stage I hypertension at one year postpartum.
Interventions
DRUGNifedipine ER
Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.
Sponsors
Medical College of Wisconsin
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines * Postpartum day 0-4 * Age ≥ 18 years * Able to communicate in English or in Spanish * Has an established OBGYN at an MCW or NU health system practice that has access to Epic electronic medical records.
Exclusion criteria
* Pre-gestational hypertension * Type 1 or type 2 diabetes mellitus * Admitted to intensive care unit at the time of screening * Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization * Getting discharged on the day of screening * Known allergy or contraindication to nifedipine ER * Inability or unwillingness to provide informed consent * Already taking long-acting antihypertensive medication for standard care * Maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic hypertension | One year postpartum | Diagnosis of chronic hypertension, defined as stage I hypertension with BP \>130/80 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial dysfunction | One year postpartum | Brachial artery flow-mediated dilation will assess endothelial dysfunction. |
| Arterial stiffness | One year postpartum | Carotid-femoral pulse wave velocity will assess arterial stiffness. |
| Cardiac structure and function | One year postpartum | Transthoracic echocardiogram will assess cardiac structure and function. |
| Unplanned healthcare utilization | After birth through one year postpartum | Unplanned hospital readmissions, emergency department visits, and clinic visits. |
| Composite severe maternal morbidity | After birth through one year postpartum | Maternal core outcomes of preeclampsia using PMID: 32674052 reference. |
| Life's Essential 8 cardiovascular health score | After birth through one year postpartum | The score (0-100) will be calculated using American Heart Association application. |
| Severe postpartum hypertension | After birth through one year postpartum | Blood pressure \>160/110 mmHg |
| ASCVD score | One year postpartum | Lifetime risk calculated for subjects \>20 years and 10-year risk calculated for subjects \> 40 years. |
Countries
United States
Contacts
CONTACTAlyssa M Hernandez, DO
CONTACTAmandla Stanley, MSN
PRINCIPAL_INVESTIGATORAnna Palatnik, MD
Medical College of Wisconsin
Outcome results
None listed