Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT07182318
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the FIGO Nutrition Checklist in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'test-retest reproducibility', 'timeFrame': '2 to 3 days between fulfillment of the questionnaire', 'description': "In most questions of the polish version of FIGO Nutrition Checklist the test-retest reproducibility was very good or excellent. Number patients who changed answers between the first and the second asssesment varied from 0 to 12.5%. The minimum-0% and maximum values-100%. The differences were not statistically significant (McNemar's test)"}], 'secondaryOutcomes': [{'measure': 'An analysis of dietary habits was conducted using the FIGO Nutrition Checklist.', 'timeFrame': '2-3 days', 'description': 'The dietary habits of the pregnant participants were analyzed using the FIGO Nutrition Checklist, with a focus on the consumption of specific food groups. The questionnaire comprises four sections: dietary requirements, anthropometric measurements (including body weight and height), and six questions assessing diet quality. The final section evaluates folic acid supplementation, sunlight exposure, and indicators of anemia among respondents. The checklist uses a binary response format ("Yes" or "No"), where negative responses may indicate potential nutritional deficiencies that warrant further assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'nutrition', 'child health', 'maternal health'], 'conditions': ['Pregnancy', 'Nutrition']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'International Federation of Gynecology and Obstetrics (FIGO). FIGO Nutrition Checklist: A tool for assessing nutrition in women of reproductive age. International Journal of Gynecology & Obstetrics, 2017: 137(2), 218-223'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study were to verify the test-retest reproducibility of FIGO Nutrition Checklist as well as evaluate dietary habits of pregnant women in the third trimester.', 'detailedDescription': 'The FIGO Nutrition Checklist was developed to evaluate nutrient intake in both the preconception and gestational periods. It allows to identify inadequate diets as well as provides feedback to women on their dietary habits. The questionnaire is available in several lenguages including polish.\n\nThe checklist employs a binary response format-"Yes" or "No." Negative responses may indicate potential nutritional deficits requiring further evaluation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'either outpatients attending the obstetrics clinic or inpatients at the Department of Obstetrics and Gynecology at the Independent Public Health Care Facility in Puławy', 'genderDescription': 'pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age was 35 weeks ± 3 days.\n\nExclusion Criteria:\n\n* terminal disease of the baby\n* diabetes\n* severe hypertension\n* IUGR'}, 'identificationModule': {'nctId': 'NCT07182318', 'briefTitle': 'Validation of the FIGO Nutrition Checklist in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'Validation and Application of the FIGO Nutrition Checklist in the Third Trimester Pregnant Women.', 'orgStudyIdInfo': {'id': '01/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'third trimester pregnant women', 'description': 'ither outpatients attending the obstetrics clinic or inpatients at the Department of Obstetrics and Gynecology at the Independent Public Health Care Facility in Puławy.', 'interventionNames': ['Diagnostic Test: The FIGO Nutrition Checklist']}, {'label': 'At the time of dietary assessment, the mean gestational age was 35 weeks ± 3 days', 'interventionNames': ['Diagnostic Test: The FIGO Nutrition Checklist']}], 'interventions': [{'name': 'The FIGO Nutrition Checklist', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['The FIGO Nutrition Checklist after 2-3 days'], 'description': 'patient fulfilled the questionnaire twice. period of time 2-3 days', 'armGroupLabels': ['At the time of dietary assessment, the mean gestational age was 35 weeks ± 3 days', 'third trimester pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24-100', 'city': 'Puławy', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Zakład Opieki Zdrowotnej w Puławach', 'geoPoint': {'lat': 51.41655, 'lon': 21.96939}}], 'overallOfficials': [{'name': 'Michał Bogusiewicz, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Lublin'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'we plan to publish i 2025 year', 'ipdSharing': 'YES', 'description': 'we plan to publish the data', 'accessCriteria': 'everybody who will read the publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Katarzyna Skorupska', 'investigatorAffiliation': 'Medical University of Lublin'}}}}