Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Traditional clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension
|
Procedure: Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension
Patients are treated for hypertension if SBP >= 160 mmHg.
|
| Updated clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension
|
Procedure: Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension
Patients are treated for hypertension if SBP >= 180 mmHg.
|
Outcome Measures
Primary Outcome Measures
- 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. [during the time of delivery hospitalization (about 2 days to 3 months)]
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.
Secondary Outcome Measures
- 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 [5 minutes after birth]
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.
- 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)]
Eligibility Criteria
Criteria
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)
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A history of stroke, CHF, chronic kidney disease (CKD), MI
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Have Hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome or thrombocytopenia (platelets < 100×10^9/L)
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Persistent neurologic symptoms including headache >8/10 one hour after analgesic or blurry vision/loss of vision
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Kristen Cagino, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-23-0241