Observing outcomes of changing blood pressure treatment thresholds in pregnant women with hypertension
An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
This study looks at how changing the blood pressure treatment guidelines affects the health of pregnant women with high blood pressure and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 540 (estimated) |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05881252 on ClinicalTrials.gov |
What this trial studies
This study aims to observe the outcomes of maternal hypertension management before and after a change in clinical practice regarding blood pressure treatment thresholds during pregnancy and the postpartum period. Initially, outcomes will be monitored for 10 months using the traditional threshold of 160 mmHg for acute treatment. Following a month of education on the new threshold of 180 mmHg, the study will continue to observe outcomes for an additional 10 months under the updated guidelines. This observational approach will help assess the impact of the new treatment criteria on perinatal outcomes.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals over 20 weeks' gestation with blood pressure readings of 160/110 mmHg or higher.
Not a fit: Patients with active severe complications such as seizures, stroke, or heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of maternal hypertension, potentially enhancing maternal and fetal health outcomes.
How similar studies have performed: While this approach is observational, similar studies have indicated that changes in clinical guidelines can significantly impact patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- UT Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kristen Cagino, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Kristen Cagino, MD
- Email: Kristen.A.Cagino@uth.tmc.edu
- Phone: 713-500-6412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.