Clinical trial NCT05881252: Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
Official title: An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maternal Hypertension
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 540
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any individual \> 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) in Houston, Texas and with blood pressure with \>= 160/110 mmHg

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).


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

Primary outcomes:
measure: 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.
timeFrame: during the time of delivery hospitalization (about 2 days to 3 months)
Secondary outcomes:
measure: Number of patients with non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery
timeFrame: at the time of delivery
measure: Number of patients with Apgar score < 7 at 5 min
timeFrame: 5 minutes after birth
measure: Number of patients with eclampsia
timeFrame: during the time of delivery hospitalization (about 2 days to 3 months)
measure: Number of patients with placental abruption
timeFrame: during the time of delivery hospitalization (about 2 days to 3 months)
measure: Number of patients with posterior reversible encephalopathy syndrome (PRES)
timeFrame: during the time of delivery hospitalization (about 2 days to 3 months)
measure: Number of patients with hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome
timeFrame: during the time of delivery hospitalization (about 2 days to 3 months)
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kristen Cagino, MD
role: PRINCIPAL_INVESTIGATOR
References: