Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
- Conditions
- Maternal Hypertension
- Interventions
- Procedure: Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertensionProcedure: Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension
- Registration Number
- NCT05881252
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 540
- any individual > 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) and with blood pressure with >= 160/110 mmHg
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Updated clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension - Traditional clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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)
Trial Locations
- Locations (1)
UT Houston
🇺🇸Houston, Texas, United States