Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension

An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension

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).

Study Overview

• Status: Recruiting
• Conditions: Maternal Hypertension
• Intervention / Treatment: Procedure: Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension; Procedure: Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension

• Study Type: Observational
• Enrollment (Estimated): 540

Contacts and Locations

• Study Contact: Name: Kristen Cagino, MD; Phone Number: 713-500-6412; Email: Kristen.A.Cagino@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Recruiting
      • UT Houston
      • Contact: Kristen A Cagino, MD; Phone Number: 518-859-8312; Email: kristen.a.cagino@uth.tmc.edu
      • Contact: Baha Sibai, MD; Phone Number: 513-602-6295; Email: baha.m.sibai@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	during the time of delivery hospitalization (about 2 days to 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	5 minutes after birth
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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Kristen Cagino, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HSC-MS-23-0241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No