Maternal Hypertension
Conditions
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).
Interventions
PROCEDUREClinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension
Patients are treated for hypertension if SBP \>= 160 mmHg.
PROCEDUREClinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension
Patients are treated for hypertension if SBP \>= 180 mmHg.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery | at the time of delivery | — |
| 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 placental abruption | during the time of delivery hospitalization (about 2 days to 3 months) | — |
Countries
United States
Outcome results
None listed