Preeclampsia Clinical Trial
Official title:
Best Practice Alert (BPA) for Low Dose Aspirin Recommendation in High-risk Pregnancies: a Randomized Controlled Trial
NCT number | NCT05802940 |
Other study ID # | LDA BPA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 19, 2023 |
Est. completion date | June 19, 2025 |
The goal of this study is to assess the effect of an electronic health record (EHR) clinical decision support tool, also known as a best practice alert (BPA), on healthcare provider recommendations for low dose aspirin use in a high-risk pregnant patient population. The investigators hypothesize that the implementation of the EHR BPA tool will increase the healthcare provider's recommendation for low dose aspirin compared to current standard care.
Status | Recruiting |
Enrollment | 640 |
Est. completion date | June 19, 2025 |
Est. primary completion date | June 19, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Receiving prenatal care within Geisinger - Initial prenatal visit prior to 28 weeks gestation - Determined to be high risk for preeclampsia based on the modified United States Preventive Services Task Force and American College of Obstetrics and Gynecology criteria (at least 1 high risk factor) Exclusion Criteria: - Not pregnant - No prenatal visit prior to 28 weeks gestation - Maternal-Fetal Medicine only visits - Not meeting the modified USPSTF high-risk criteria - Contraindication to aspirin, including allergy |
Country | Name | City | State |
---|---|---|---|
United States | Geisinger Medical Center | Danville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Geisinger Clinic |
United States,
ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708. — View Citation
US Preventive Services Task Force; Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Li L, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Stevermer J, Tseng CW, Wong JB. Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Sep 28;326(12):1186-1191. doi: 10.1001/jama.2021.14781. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient taking low dose aspirin | yes/no | Assessed at time of delivery (>/= 28 weeks) | |
Other | Rate of preeclampsia | yes/no | Assessed at time of delivery | |
Other | Timing of low dose aspirin recommendation | gestational age (weeks) | Assessed between initial prenatal visit to delivery (>/= 28 weeks) | |
Other | Timing of low dose aspirin initiation | gestational age (weeks) | Assessed between initial prenatal visit to delivery (>/= 28 weeks) | |
Other | Preterm delivery | yes/no | Assessed at delivery | |
Other | Provider response to best practice alert | recommended, declined, etc. | Assessed between initial prenatal visit to delivery (>/= 28 weeks) | |
Other | Number of times the best practice alert fired for a patient | 1,2,3,4... | Assessed between initial prenatal visit to delivery (>/= 28 weeks) | |
Primary | A sensitivity analysis of the healthcare provider recommendation for low dose aspirin use in patients, specifically those who deliver after 28 weeks | yes/no | Assessed between initial prenatal visit and delivery after 28 weeks | |
Secondary | The healthcare provider recommendation for low dose aspirin use in all randomized patients | yes/no | Assessed between initial prenatal visit and delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03510286 -
Validation of a PrCr Dipstick Diagnostic Test in Ghana
|
||
Recruiting |
NCT03313024 -
Berlin-Brandenburg Pregnancy Cohort
|
||
Active, not recruiting |
NCT04990141 -
Molecular Screening Method for Preeclampsia (PREMOM)
|
||
Completed |
NCT02147626 -
Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia
|
N/A | |
Not yet recruiting |
NCT05999851 -
Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
|
N/A | |
Recruiting |
NCT02923206 -
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
|
N/A | |
Terminated |
NCT02558023 -
The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine
|
Phase 3 | |
Completed |
NCT02384226 -
User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
|
||
Withdrawn |
NCT05016440 -
Lisinopril for Renal Protection in Postpartum Preeclamptic Women
|
N/A | |
Completed |
NCT02554604 -
Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
|
||
Completed |
NCT02854501 -
Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
|
||
Not yet recruiting |
NCT02541110 -
Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler
|
N/A | |
Recruiting |
NCT02337049 -
Preeclampsia Subtypes and Surrogate Markers of CVD Risk
|
N/A | |
Recruiting |
NCT02247297 -
Pancreatic Stone Protein (PSP) in Pregnant Women
|
||
Completed |
NCT02238704 -
Cornell University-Micronutrient Initiative Calcium Supplementation Study
|
N/A | |
Completed |
NCT01195441 -
Prediction and Prevention of Preeclampsia by First Trimester Ultrasound
|
N/A | |
Withdrawn |
NCT01179542 -
The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR
|
N/A | |
Completed |
NCT00456118 -
Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
|
||
Recruiting |
NCT00117546 -
Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia
|
Phase 4 | |
Completed |
NCT00787241 -
Platelet Count Trends in Pre-eclamptic Parturients
|
N/A |