Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
Study NCT ID:
NCT04116268
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2019-10-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'ACTUAL', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who develop pregnancy-induced hypertension', 'timeFrame': '9 months'}, {'measure': 'Number of neonates who require neonatal intensive care unit admission', 'timeFrame': '9 months'}, {'measure': 'Number of participants who develop pre-eclampsia', 'timeFrame': '9 months'}, {'measure': 'Number of participants who require primary caesarian section', 'timeFrame': '9 months'}, {'measure': 'Gestational age at delivery', 'timeFrame': '9 months'}, {'measure': 'Number of stillbirth', 'timeFrame': '9 months'}, {'measure': 'Number of preterm delivery', 'timeFrame': '9 months'}, {'measure': 'Number of macrosomia at delivery', 'timeFrame': '9 months', 'description': 'Birth weight more than 4000g'}, {'measure': 'Number of low birth weight at delivery', 'timeFrame': '9 months', 'description': 'Birth weight less than 2500g'}, {'measure': 'Birth weight', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "The participants are divided into subjects or controls based on the BMI taken during the first trimester of pregnancy upon recruitment. Participants with a BMI of ≥23kg/m2 were recruited as subjects (labelled as obese group) and those with BMI of 18.5-23kg/m2 were recruited as controls. Total gestational weight gain was calculated based on the difference between third trimester weight and first trimester weight. All participants who fulfilled the inclusion and exclusion criteria were recruited after informed consent. Demographic data of all participants were recorded. At first trimester, the participants' weight and height were recorded for calculation of BMI. At every trimester visit, the following were recorded: i) blood pressure using sphygmomanometer after 15 minutes of rest ii) mid-stream urine for presence of proteinuria iii) weight. The participants were followed up until the point of delivery. Occurrence of adverse pregnancy outcome, fetal outcome, and birth weight were documented. The pregnancy outcomes measured in this study included the need of primary caesarian section, the occurrence of pregnancy-induced hypertension (PIH), pre-eclampsia, and gestational age at delivery. The neonatal outcomes measured in this study included neonatal intensive care unit (NICU) admission, stillbirth, preterm delivery, occurrence of macrosomia and low birth weight, and neonatal birth weight."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant during first trimester', 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First trimester of pregnancy\n* Aged 18 years or older\n* Able to come for follow up at least once per trimester\n\nExclusion Criteria:\n\n* Underlying diabetes mellitus\n* Gestational diabetes mellitus diagnosed via OGTT\n* Known genetic disorders affecting growth at time of recruitment\n* Known congenital anomalies at time of recruitment\n* Conceived via artificial insemination\n* Hepatitis B/C/HIV infection'}, 'identificationModule': {'nctId': 'NCT04116268', 'briefTitle': 'The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers', 'organization': {'class': 'OTHER', 'fullName': 'University Malaysia Sarawak'}, 'officialTitle': 'The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers', 'orgStudyIdInfo': {'id': 'F05/SpGS/1548/2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obesity', 'description': 'BMI \\>23kg/m2'}, {'label': 'Control', 'description': 'BMI 18-22.9kg/m2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94300', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Universiti Malaysia Sarawak', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}], 'overallOfficials': [{'name': 'Huai Heng Loh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Malaysia Sarawak'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Malaysia Sarawak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Dr.', 'investigatorFullName': 'Dr Huai Heng, Loh', 'investigatorAffiliation': 'University Malaysia Sarawak'}}}}