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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05881252
Other study ID # HSC-MS-23-0241
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
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Recruiting NCT05551104 - Safest Choice of Antihypertensive Regimen for Postpartum Hypertension Phase 3