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

The University of Texas System (UT)

Status: Completed

Conditions: Maternal Hypertension

Treatments: 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

Funder types: Other

Identifiers

NCT05881252

HSC-MS-23-0241

Details and patient eligibility

About

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).

Enrollment: 1,003 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,003 participants in 2 patient groups

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

Treatment:

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

Treatment:

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