An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Maternal Hypertension
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 1003
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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).
Investigators
Kristen Cagino
Fellow
The University of Texas Health Science Center, Houston
Eligibility 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)
- •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
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- 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))
- 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)
- Number of patients with placental abruption(during the time of delivery hospitalization (about 2 days to 3 months))
- Number of patients with eclampsia(during the time of delivery hospitalization (about 2 days to 3 months))