Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-30 @ 4:12 PM
Study NCT ID:
NCT04777903
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2021-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Pre-pregnancy BMI and Weight Gain and Outcomes in Women With Twin Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2021-02-28', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of gestational diabetes mellitus, gestational hypertension and small for gestational age', 'timeFrame': '35 weeks to 40 weeks gestation', 'description': 'pregnant outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Twin Pregnancy; Body Mass Index; Weight Gain; Pregnancy Outcome']}, 'descriptionModule': {'briefSummary': 'Prepregnancy body mass index (BMI) and gestational weight gain (GWG) have Significant effects on the risk of pregnancy outcomes such as gestational hypertension disease and gestational diabetes mellitus in singleton pregnancies. This paper is to investigate the relationship between pre-pregnancy body mass index (BMI) and weight gain during pregnancy and pregnancy outcomes in women with twin pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The participants include women with twin pregnancy meeting the inclusion criteria', 'genderDescription': 'Eligible participants is female.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 \\~ 41 years old;\n* The gestational age of the first diagnosed twin pregnancy is ≤10weeks;\n* Double chorionic double amniotic sac pregnancy;\n\nExclusion Criteria:\n\n* with heart disease, liver disease, kidney disease, complications (chronic hypertension, hyperthyroidism, diabetes and others ), genetic diseases, psychological and mental diseases;\n* with history of habitual abortion and cervical insufficiency;'}, 'identificationModule': {'nctId': 'NCT04777903', 'briefTitle': 'The Relationship Between Pre-pregnancy BMI and Weight Gain and Outcomes in Women With Twin Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'The Relationship Between Pre-pregnancy Body Mass Index (BMI) and Pregnancy Weight Gain and Pregnancy Outcomes in Women With Twin Pregnancy', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2021-07-201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'underweight woman with twin pregnancy', 'description': 'underweight (BMI \\< 18.5 kg/m2)', 'interventionNames': ['Other: collect date about all participants']}, {'label': 'normal weight woman with twin pregnancy', 'description': 'normal (BMI: 18.5-23.9 kg/m2)', 'interventionNames': ['Other: collect date about all participants']}, {'label': 'overweight and obese woman with twin pregnancy', 'description': 'overweight and obese (BMI ≥24 kg/m2)', 'interventionNames': ['Other: collect date about all participants']}], 'interventions': [{'name': 'collect date about all participants', 'type': 'OTHER', 'description': 'a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.', 'armGroupLabels': ['normal weight woman with twin pregnancy', 'overweight and obese woman with twin pregnancy', 'underweight woman with twin pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ying hua, Doctor', 'role': 'CONTACT', 'email': 'wzfeyhy1015@126.com', 'phone': '13676403165'}], 'facility': 'department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Ying Hua', 'role': 'CONTACT', 'email': 'wzfeyhy1015@126.com', 'phone': '+8613676403165', 'phoneExt': '+8613676403165'}], 'overallOfficials': [{'name': 'Ying Hua', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}