Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-20 @ 12:45 PM
Study NCT ID:
NCT03154268
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10422}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preeclampsia', 'timeFrame': 'After 20th gestational weeks till delivery, about 5 months', 'description': 'Maternal systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg during gestation. Urine protein ≥5.0 g within 24h, urine volume \\<400 mL. HELLP syndrome or pulmonary edema present.'}, {'measure': 'Eclampsia', 'timeFrame': 'After 20th gestational weeks till delivery, about 5 months', 'description': 'Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.'}, {'measure': 'ICP', 'timeFrame': 'After 14th gestational weeks till delivery, about 6 months', 'description': 'Intrahepatic cholestasis of pregnancy.'}, {'measure': 'Placenta previa', 'timeFrame': 'During pregnancy till delivery', 'description': 'Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.'}, {'measure': 'Gestational diabetes', 'timeFrame': 'After 24th gestational weeks, about 4 months', 'description': 'By oral glucose tolerance test between 24th and 28th gestational weeks (fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, 2-h glucose ≥8.5 mmol/L; one abnormal result sufficient).'}, {'measure': 'Ruptured uterus', 'timeFrame': 'During delivery', 'description': 'Rupture of maternal uterus confirmed by laparotomy.'}, {'measure': 'Placental abruption', 'timeFrame': 'After 20th gestational weeks till delivery, about 5 months', 'description': 'Abruption of a normally positioned placenta before delivery, diagnosed by clinical symptoms, ultrasound, fetal heart monitoring, or laboratory tests.'}, {'measure': 'Postpartum hemorrhage', 'timeFrame': 'Within 24h after delivery', 'description': 'Postpartum bleeding volume ≥500 mL.'}, {'measure': 'Hepatic diseases', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'Hepatitis-B/C/E virus infection, acute fatty liver disease, or severe hepatitis.'}, {'measure': 'Hematological diseases', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'Iron-deficiency anemia, thalassemia, hemophilia, idiopathic thrombocytopenic purpura, aplastic anemia, or disseminated intravascular coagulation.'}, {'measure': 'Gynecological diseases', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'Uterine fibroids, ovarian cyst, cervical carcinoma, pelvic inflammation, or ovarian carcinoma.'}, {'measure': 'Respiratory diseases', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'Pneumonia, bronchitis, asthma or pulmonary tuberculosis.'}, {'measure': 'Thyroid disease', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'Hyperthyroidism or hypothyroidism.'}, {'measure': 'ICU admission', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'Admission to intensive care unit.'}, {'measure': 'Maternal death', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'Maternal death.'}, {'measure': 'Macrosomia', 'timeFrame': 'within 1 month after delivery', 'description': 'Birth weight \\>4000 g.'}, {'measure': 'Infant of low-birth weight', 'timeFrame': 'within 1 month after delivery', 'description': 'Birth weight \\<2500 g.'}, {'measure': 'Neonatal ICU admission', 'timeFrame': 'Within 1 month after delivery', 'description': 'Admission to neonatal intensive care unit.'}, {'measure': 'Neonatal death', 'timeFrame': 'Within 1 month after delivery', 'description': 'Neonatal death.'}, {'measure': 'Large for gestational age', 'timeFrame': 'Within 1 month after delivery', 'description': 'Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.'}, {'measure': 'Small for gestational age', 'timeFrame': 'Within 1 month after delivery', 'description': 'Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.'}, {'measure': 'Neonatal defect', 'timeFrame': 'Within 1 month after delivery', 'description': 'Neonatal defect.'}, {'measure': 'Maternal adverse outcomes', 'timeFrame': 'During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year', 'description': 'There occurred one or more of preeclampsia, eclampsia, ICP, placenta previa, gestational diabetes, ruptured uterus, placental abruption, postpartum hemorrhage, hepatic diseases, hematological diseases, gynecological diseases, respiratory diseases, thyroid disease, ICU admission, or maternal death.'}, {'measure': 'Neonatal adverse outcomes', 'timeFrame': 'Within 1 month after delivery', 'description': 'There occurred one or more of macrosomia, low-birth weight, neonatal ICU admission, neonatal death, large for gestational age, small for gestational age, or neonatal defect.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational weight gain', 'Chinese pregnant women', 'Retrospective longitudinal study', 'China', 'IOM guideline', 'Adverse outcome', 'Model'], 'conditions': ['Gestational Weight Gain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the reference ranges and rates of gestational weight gain among Chinese pregnant women, and to analyze the correlation between gestational weight gain and adverse outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Deliveries between January 2013 and December 2014;\n2. Gestational age between 37 weeks or older and less than 42 weeks;\n3. Registration with care documents at the first prenatal visit prior to the 15th gestational week;\n4. Had at least five follow-up visits until delivery.\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT03154268', 'acronym': 'GWGCPW', 'briefTitle': 'Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women', 'orgStudyIdInfo': {'id': 'GWG-China-2016'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xin Sun, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'West China Second University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chinese Evidence-based Medicine Center', 'investigatorFullName': 'Jing Tan', 'investigatorAffiliation': 'West China Hospital'}}}}