- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06694233
Improving Aspirin Prescription Rates in Outpatient Clinic
Aspirin Prescription For Moderate- and High-Risk Obstetric Population in Outpatient Clnic; A Quality Improvement Project.
Ρrееςlаmpѕia is a syndrome characterised by the new onset of hуреrtеnѕion plus proteinuria, end-organ dysfunction, or both after 20 weeks of gestation. It complicates 3-5% of pregnancies.
Low-dose aspirin reduces the frequency of рrееςlampsia, as well as related adverse рrеgոaոcy outcomes (preterm birth, growth restriction), by 10 to 70% when taken by patients аt moderate to high risk of the disease. It has an excellent maternal/fetal safety profile. Thus, it is a reasonable preventive strategy for these patients.
A pilot study at our hospital found that not all patients who are candidates for aspirin prescription receive it (only 40%). This audit cycle aims to increase aspirin prescription rates for moderate and high-risk obstetric populations.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ahmadi, Kuwait, 47000
- Adan hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Women at high risk are those with any of the following:
- hypertensive disease during a previous pregnancy
- chronic kidney disease
- autoimmune disease such as systemic lupus erythematosus or antiphospholipid syndrome
- type 1 or type 2 diabetes
- chronic hypertension.
Women with more than one moderate risk factor, such as are:
- nulliparity
- age 40 years or older
- pregnancy interval of more than 10 years
- body mass index (BMI) of 35 kg/m2 or more at first visit
- family history of pre-eclampsia
- multi-fetal pregnancy.
Exclusion Criteria:
- None. All eligible candidates will be included.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obstetric population candidate for aspirin prescription
Moderate- and high-risk obstetric population
|
Improving aspirin prescription rates for candidate patients (moderate- and high-risk obstetric population)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Aspirin prescription
Time Frame: Six months
|
Six months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Singh N, Shuman S, Chiofalo J, Cabrera M, Smith A. Missed opportunities in aspirin prescribing for preeclampsia prevention. BMC Pregnancy Childbirth. 2023 Oct 7;23(1):717. doi: 10.1186/s12884-023-06039-w.
- Kumar NR, Speedy SE, Song J, Welty LJ, Cavens AD. Quality Improvement Initiative for Aspirin Screening and Prescription Rates for Preeclampsia Prevention in an Outpatient Obstetric Clinic. Am J Perinatol. 2024 May;41(S 01):e917-e921. doi: 10.1055/s-0042-1759705. Epub 2022 Dec 30.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Body Weight
- Pregnancy Complications
- Hypertension, Pregnancy-Induced
- Pre-Eclampsia
- Birth Weight
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Fibrin Modulating Agents
- Antirheumatic Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Antipyretics
- Anti-Inflammatory Agents, Non-Steroidal
- Cyclooxygenase Inhibitors
- Fibrinolytic Agents
- Platelet Aggregation Inhibitors
- Aspirin
Other Study ID Numbers
- QIP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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