Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-19 @ 2:00 PM
Study NCT ID:
NCT03448432
Status:
UNKNOWN
Last Update Posted:
2018-03-05
First Post:
2018-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence Study of the Etiology of Pregnancy Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-12-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of the etiologies of anemias occured during pregnancy', 'timeFrame': 'from date of inclusion until 6 weeks after delivery', 'description': 'Anemia in pregnancy is defined as hemoglobin level (Hb) \\< 11 g/dL in the first and the third trimesters, and Hb \\< 10.5 g/dL in the second trimester.'}], 'secondaryOutcomes': [{'measure': 'Study of obstetrical complications in women with anemia', 'timeFrame': 'from date of inclusion until delivery', 'description': '* Measure of the incidence of postpartum haemorrhage, instrumental extractions, caesareans sections, premature delivery, intra-uterine growth restriction or small for gestational age, placenta abruption, preeclampsia and low birth-weight newborn (\\<3rd and \\<10th percentile under neonatal morphometry curves)\n* Level of release,\n* 1-, 3- and 5-minutes Apgar score,\n* Arterial ans venous cord potential hydrogen (pH)'}, {'measure': 'Study of the evolution of anemia during pregnancy and postpartum', 'timeFrame': 'from date of inclusion until 6 weeks after delivery', 'description': 'Measure of the Hb level monthly and at 6 weeks after delivery'}, {'measure': 'Describe the etiological and therapeutic management of pregnancy anemias', 'timeFrame': 'from date of inclusion until 6 weeks after delivery', 'description': 'therapeutic management : etiologic treatment (supplemental iron, vitaminic replacement, others) and symptomatic treatment (numbers and rhythm of transfusions)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy Anemia'], 'conditions': ['Pregnancy Anemia']}, 'descriptionModule': {'briefSummary': 'Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant woman with anemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* woman 18-years or older\n* woman with a normal pregnancy\n* anemia with accidental or symptomatic discovery, whatever the term of pregnancy\n* non opposition collected\n\nExclusion Criteria:\n\n* Refuse to participate\n* Stopped pregnancy whatever the term\n* Medical abortion of pregnancy'}, 'identificationModule': {'nctId': 'NCT03448432', 'acronym': 'PREGAN', 'briefTitle': 'Prevalence Study of the Etiology of Pregnancy Anemia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Prevalence Study of the Etiologies of Pregnancy Anemias', 'orgStudyIdInfo': {'id': 'PREGAN (29BRC17.0155)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Anne Couturier', 'role': 'CONTACT', 'email': 'marie-anne.couturier@chu-brest.fr'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Marie-Anne Couturier', 'role': 'CONTACT', 'email': 'marie-anne.couturier@chu-brest.fr', 'phone': '0298223421'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}