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

Maternal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881252
• Other study ID #: HSC-MS-23-0241
• Status: Recruiting
• Start date: May 11, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Kristen Cagino, MD
• Phone: 713-500-6412
• Email: Kristen.A.Cagino[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Maternal Hypertension

Intervention

Procedure:
• Clinical blood pressure threshold of SBP >= 160 mmHg for acute treatment of hypertension
Patients are treated for hypertension if SBP >= 160 mmHg.
• Clinical blood pressure threshold of SBP >= 180 mmHg for acute treatment of hypertension
Patients are treated for hypertension if SBP >= 180 mmHg.

Locations

Country	Name	City	State
United States	UT Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery		at the time of delivery
Secondary	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
Secondary	Number of patients with eclampsia		during the time of delivery hospitalization (about 2 days to 3 months)
Secondary	Number of patients with placental abruption		during the time of delivery hospitalization (about 2 days to 3 months)
Secondary	Number of patients with posterior reversible encephalopathy syndrome (PRES)		during the time of delivery hospitalization (about 2 days to 3 months)
Secondary	Number of patients with hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome		during the time of delivery hospitalization (about 2 days to 3 months)