Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT03332706
Status:
UNKNOWN
Last Update Posted:
2017-11-06
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Association Between Blood's and Urinary Heavy Metal Level in Pregnant Women and the Spontaneous Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075322', 'term': 'Heavy Metal Poisoning'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "blood's and urinary heavy metal level", 'timeFrame': '12months', 'description': '6 kinds of heavy metal:Pb,As,Hg,Gd,Cr,Se'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heavy Metal Toxicity', 'Spontaneous Abortion']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to define the possible association between heavy iron level and the consequence of pregnancy especially spontaneous abortion and missed abortion. The study population will comprised the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November. We categorised the patients into two groups, the study group where the patients suffered from spontaneous abortion or missed abortion, and the control group where the patients carry the normal live fetal for at least 8 weeks and ask for artificial abortion. All the cases included in the study were examined with respect to 6 kinds of heavy iron level in venous blood and urine, then correlation analysis was applied to define heavy iron level between two groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- early trimester pregnant women\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03332706', 'acronym': 'HMLandSA', 'briefTitle': "the Association Between Blood's and Urinary Heavy Metal Level in Pregnant Women and the Spontaneous Abortion", 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Department of Gynecology and Obstetrics From Peking Union Medical College Hospital', 'orgStudyIdInfo': {'id': 'HML2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SG', 'description': 'Study Group is the group where the patients during observation suffer from spontaneous abortion or missed abortion,', 'interventionNames': ['Other: observation']}, {'label': 'CG', 'description': 'Control Group is where the patients carry the normal live fetal for at least 8 weeks', 'interventionNames': ['Other: observation']}], 'interventions': [{'name': 'observation', 'type': 'OTHER', 'description': 'after the subjects are included into the groups,they are asked to do a questionaire.Then,we just observe the outcomes of pregnancy', 'armGroupLabels': ['CG', 'SG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Pekin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu xinyan, professor', 'role': 'CONTACT', 'email': 'liuxymeng@163.com', 'phone': '18600008013'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liu xinyan', 'role': 'CONTACT', 'email': 'liuxymeng@163.com', 'phone': '18600008013'}], 'overallOfficials': [{'name': 'Liu xinyan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}