Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 6:13 PM
Study NCT ID:
NCT06694233
Status:
TERMINATED
Last Update Posted:
2025-07-10
First Post:
2024-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Aspirin Prescription Rates in Outpatient Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-04', 'size': 167567, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-02T18:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Could not obtain ethical approval yet', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aspirin prescription', 'timeFrame': 'Six months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aspirin', 'Preeclampsia', 'obstetric', 'risk population'], 'conditions': ['Low Birth Weight', 'Small for Gestational Age (SGA)', 'Preeclampsia (PE)', 'Prevention &Amp; Control']}, 'referencesModule': {'references': [{'pmid': '37805449', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36584691', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.nice.org.uk/guidance/cg107', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nLow-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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Moderate- and high- risk obstetric population', 'genderDescription': 'Obstetric population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen at high risk are those with any of the following:\n\n1. hypertensive disease during a previous pregnancy\n2. chronic kidney disease\n3. autoimmune disease such as systemic lupus erythematosus or antiphospholipid syndrome\n4. type 1 or type 2 diabetes\n5. chronic hypertension.\n\nWomen with more than one moderate risk factor, such as are:\n\n1. nulliparity\n2. age 40 years or older\n3. pregnancy interval of more than 10 years\n4. body mass index (BMI) of 35 kg/m2 or more at first visit\n5. family history of pre-eclampsia\n6. multi-fetal pregnancy.\n\nExclusion Criteria:\n\n* None. All eligible candidates will be included.'}, 'identificationModule': {'nctId': 'NCT06694233', 'briefTitle': 'Improving Aspirin Prescription Rates in Outpatient Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Aspirin Prescription For Moderate- and High-Risk Obstetric Population in Outpatient Clnic; A Quality Improvement Project.', 'orgStudyIdInfo': {'id': 'QIP1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obstetric population candidate for aspirin prescription', 'description': 'Moderate- and high-risk obstetric population', 'interventionNames': ['Other: Aspirin prescription on outpatient basis']}], 'interventions': [{'name': 'Aspirin prescription on outpatient basis', 'type': 'OTHER', 'description': 'Improving aspirin prescription rates for candidate patients (moderate- and high-risk obstetric population)', 'armGroupLabels': ['Obstetric population candidate for aspirin prescription']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47000', 'city': 'Al Ahmadi', 'state': 'Al Ahmadi', 'country': 'Kuwait', 'facility': 'Adan hospital', 'geoPoint': {'lat': 29.07694, 'lon': 48.08389}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Islam Tarek Elkhateb', 'investigatorAffiliation': 'Cairo University'}}}}