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Completed

NCT Number: NCT05881252

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

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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Key information

Conditions

Maternal Hypertension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Observational

Primary location

UT Houston

Houston, Texas, 77004, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

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

Procedure

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

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.

    Time frame: during the time of delivery hospitalization (about 2 days to 3 months)

    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.

Secondary outcomes

  1. Number of patients with non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery

    Time frame: at the time of delivery

  2. Number of patients with Apgar score < 7 at 5 min

    Time frame: 5 minutes after birth

    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.

  3. Number of patients with eclampsia

    Time frame: during the time of delivery hospitalization (about 2 days to 3 months)

  4. Number of patients with placental abruption

    Time frame: during the time of delivery hospitalization (about 2 days to 3 months)

  5. Number of patients with posterior reversible encephalopathy syndrome (PRES)

    Time frame: during the time of delivery hospitalization (about 2 days to 3 months)

  6. Number of patients with hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome

    Time frame: during the time of delivery hospitalization (about 2 days to 3 months)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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