Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension

Study Overview
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Brief Summary
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The purpose of this study is observe outcomes before and after a change in clinical practice in the threshold for management of severe hypertension in pregnancy and the post-partum period. Outcomes will be observed for 10 months under the current (traditional) clinical blood pressure threshold for acute treatment of hypertension, which is >= 160 millimeters of mercury (mmHg) systolic blood pressure (SBP). This will be followed by one month of education about rationale for the new SBP threshold of >= 180 mmHg and change of clinical guidelines. Then, there will be 10 months of observation after adopting the updated clinical threshold for acute antihypertensive treatment (>= 180 SBP).

Official Title
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An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension

Conditions
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Maternal Hypertension

Intervention / Treatment
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* Procedure: Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension
* Procedure: Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any individual > 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) and with blood pressure with >= 160/110 mmHg Exclusion Criteria: Active seizure, stroke, Congestive Heart Failure (CHF)/pulmonary edema, acute kidney injury (AKI), or myocardial infarction (MI) A history of stroke, CHF, chronic kidney disease (CKD), MI Have Hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome or thrombocytopenia (platelets < 100×10^9/L) Persistent neurologic symptoms including headache >8/10 one hour after analgesic or blurry vision/loss of vision
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traditional clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension<br> | Procedure: Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension<br>* Patients are treated for hypertension if SBP >= 160 mmHg.<br>|
| Updated clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension<br> | Procedure: Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension<br>* Patients are treated for hypertension if SBP >= 180 mmHg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or or Myocardial Ischemia. | The primary outcome is a composite outcome, and will be reported as number of patients who have Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or Myocardial Ischemia. | during the time of delivery hospitalization (about 2 days to 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery |  | at the time of delivery | 
| Number of patients with Apgar score < 7 at 5 min | The Apgar score indicates the status of the newborn infant immediately after birth. Apgar score ranges from 0-10, with a higher score indicating a better outcome. | 5 minutes after birth | 
| Number of patients with eclampsia |  | during the time of delivery hospitalization (about 2 days to 3 months) | 
| Number of patients with placental abruption |  | during the time of delivery hospitalization (about 2 days to 3 months) | 
| Number of patients with posterior reversible encephalopathy syndrome (PRES) |  | during the time of delivery hospitalization (about 2 days to 3 months) | 
| Number of patients with hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome |  | during the time of delivery hospitalization (about 2 days to 3 months) |