Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-16 @ 5:51 PM
Study NCT ID:
NCT02904720
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association between vitamin D blood level and the mode of delivery at birth', 'timeFrame': 'At delivery time', 'description': 'Presence of an association between the vitamin D blood level and the mode of delivery (Vaginal delivery, instrumentalized delivery, primary and secondary cesarean)?'}, {'measure': 'Association between vitamin D blood level and the gestational age at delivery', 'timeFrame': 'At delivery time', 'description': 'Presence of an association between the vitamin D blood level and the gestational age at delivery? Occurrence of preterm birth (before 37W) or postterm birth (after 40W)?'}, {'measure': 'Association between vitamin D blood level and newborn growth', 'timeFrame': 'From week 1 until birth', 'description': 'Presence of an association between vitamin D blood level and the occurrence of intrauterin growth retardation or small-for-gestational age child? With assessment of measure like length, weight, head perimeter.'}], 'primaryOutcomes': [{'measure': 'Prevalence of vitamin D deficiency', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': 'Number of patients with vitamin D deficiency after testing of vitamin D blood level at admission for prenatal care in our clinic'}], 'secondaryOutcomes': [{'measure': 'BMI as a risk factor for vitamin D deficiency', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': "Presence of an association between the patient's BMI and their vitamin D blood level?"}, {'measure': 'Ethnicity as a risk factor for vitamin D deficiency', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': "Presence of an association between the patient's ethnicity and their vitamin D blood level?"}, {'measure': 'Age as risk factor for vitamin D deficiency', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': "Presence of an association between the patient's age and their vitamin D blood level ?"}, {'measure': 'Period of the year as risk factor for vitamin D deficiency', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': 'Presence of an association between the period of the year at the time of the blood testing and the vitamin D blood level?'}, {'measure': 'Smoking Status as risk factor for vitamin D deficiency', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': "Presence of an association between the patient's smoking status and the vitamin D blood level ?"}, {'measure': 'Association between vitamin D blood level and gestational diabetes mellitus', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': 'Presence of an association between the vitamin D blood level and the occurrence of gestational diabetes mellitus?'}, {'measure': 'Association between vitamin D blood level and gestational hypertension and preeclampsia', 'timeFrame': 'Between the 1th and the 36th week of pregnancy', 'description': 'Presence of an association between the vitamin D blood level and the occurrence of gestational hypertension and preeclampsia ?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D; Pregnancy'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '32502277', 'type': 'DERIVED', 'citation': 'Christoph P, Challande P, Raio L, Surbek D. High prevalence of severe vitamin D deficiency during the first trimester in pregnant women in Switzerland and its potential contributions to adverse outcomes in the pregnancy. Swiss Med Wkly. 2020 May 28;150:w20238. doi: 10.4414/smw.2020.20238. eCollection 2020 May 18.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at the investigators' clinic. The further purposes are to identify the population at risk for vitamin D deficiency and to analyse whether vitamin D deficiency is associated with pregnancy complications."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the pregnant women attending prenatal care and giving birth at birth at our clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women attending prenatal care at our clinic who had a vitamin D blood-testing at admission\n\nExclusion Criteria:\n\n* Pregnant women lost to follow-up, Birth outside our clinic'}, 'identificationModule': {'nctId': 'NCT02904720', 'acronym': 'PCVDDPWS', 'briefTitle': 'Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Prevalence and Consequences of Vitamin D Deficiency in Pregnant Women in Switzerland', 'orgStudyIdInfo': {'id': '2015-00063'}}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Daniel Surbek, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Significantis GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}