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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1003 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-11

Study Completion Date

2024-04-04

Brief Summary

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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).

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Detailed Description

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Conditions

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Maternal Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

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

Intervention Type PROCEDURE

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

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

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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No