Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT07271758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical staff training percentage', 'timeFrame': '60 days from activation', 'description': 'Percent of eligible clinical staff completing training'}, {'measure': 'Docosahexaenoic Acid (DHA) status', 'timeFrame': 'up to week 20 gestation', 'description': 'Percent of screened patients with low DHA (\\<5% of total fatty acids)'}], 'primaryOutcomes': [{'measure': 'Screening uptake percentage', 'timeFrame': 'First 20 weeks of pregnancy', 'description': 'Percent of eligible patients who receive DHA screening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DHA', 'Omega-3 fatty acids', 'Pregnancy'], 'conditions': ['Nutrient Deficiency']}, 'descriptionModule': {'briefSummary': 'This pilot study will explore feasibility of routine implementation of the recommended blood-based screening of DHA status in early pregnancy in routine clinical care.', 'detailedDescription': 'This pilot study will be conducted within the Atrium Health Wake Forest Baptist general academic obstetric practice that serves patients in six clinic locations in the Winston-Salem area. The study will train clinical staff on the prenatal omega-3 evidence; work with Epic IT to add the DHA blood test to the early prenatal lab order set; provide screening results with interpretation to patients and clinicians via Epic; monitor uptake of screening and viewing of results; and review screening results and characteristics of screened patients. This pilot data will inform the design of a cluster randomized trial to compare DHA blood screening with US usual care on preterm birth outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients initiating prenatal care at participating clinics who are eligible for early pregnancy blood testing per American College of Obstetricians and Gynecologists (ACOG) standards\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07271758', 'acronym': 'PROmega', 'briefTitle': 'PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy', 'orgStudyIdInfo': {'id': 'IRB00140664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DHA blood screening', 'description': 'Measurement of DHA as percent of total fatty acids in red blood cells', 'interventionNames': ['Other: DHA blood screening']}], 'interventions': [{'name': 'DHA blood screening', 'type': 'OTHER', 'description': 'Measure of DHA as percent of total fatty acids in red blood cells', 'armGroupLabels': ['DHA blood screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Katherine Sauder, PhD', 'role': 'CONTACT', 'email': 'katherine.sauder@advocatehealth.org', 'phone': '336-716-1280'}], 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Katherine Sauder, PhD', 'role': 'CONTACT', 'email': 'katherine.sauder@advocatehealth.org', 'phone': '336-716-1280'}], 'overallOfficials': [{'name': 'Katherine Sauder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing data is outside the scope of this pilot study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}