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

NCT05881252 | Completed

• 1 other identifier: HSC-MS-23-0241
• Study Type: observational
• Target: 1,003
• Locations: 1 country
• Sites: 1

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).

Conditions

Maternal Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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)

Study Arms (2)

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

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

Interventions

Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension PROCEDURE

Patients are treated for hypertension if SBP \>= 160 mmHg.

Traditional clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension

Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension PROCEDURE

Patients are treated for hypertension if SBP \>= 180 mmHg.

Updated clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• any individual \> 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) and with blood pressure with \>= 160/110 mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UT Houston

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kristen Cagino, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 31, 2023
• Study Start: May 11, 2023
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)