Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 3:22 AM
Study NCT ID:
NCT02788305
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2016-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'route of delivery vaginal or caesarean section.', 'timeFrame': '48 hours from the start of induction', 'description': 'Partogram is used to access the progress of labour'}], 'secondaryOutcomes': [{'measure': 'maternal haemorrhage', 'timeFrame': '48 hours from the start of induction', 'description': 'Calculating number of soaked pads'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Induced; Birth']}, 'referencesModule': {'references': [{'pmid': '29610945', 'type': 'DERIVED', 'citation': 'Maged AM, El-Semary AM, Marie HM, Belal DS, Hany A, Taymour MA, Omran EF, Elbaradie SMY, Mohamed MAK. Effect of maternal obesity on labor induction in postdate pregnancy. Arch Gynecol Obstet. 2018 Jul;298(1):45-50. doi: 10.1007/s00404-018-4767-8. Epub 2018 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'This study investigate the progression of labour in 144 normal weight pregnant women (BMI \\<30) and 144 obese pregnant women (BMI \\>30) , not in labor admitted for induction of labor. These women are to be investigated for success of induction of labor.', 'detailedDescription': '* This prospective study will be conducted for 144 obese and 144 non obese ), post date (\\>41 wks), not in labor.\n* Woman is classified as obese if BMI \\>=30.\n* Prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation.\n* First informed consent will be obtained.\n* Determination of gestational age\n* Proper history taking, general and abdominal examinations will be done then digital examination will be performed to determine bishop score.\n* And obstetric U/S scan will be done and by which the following data will be obtained :\n\n * Fetal biometry\n * Fetal heart activity\n * Presentation\n * Localization of the placenta.\n * Amount of amniotic fluid.\n * Exclude multifetal pregnancy.\n* Induction of labor will be done using vaginal misoprostol according to the estimated Bishop score.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '144 pregnant women with BMI \\>= 30 and 144 pregnant women with BMI \\<30, post date \\>= 41 wks, not in labor admitted in Kaselaini H for induction of labor.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman.\n\n * Post date \\>= 41 weeks.\n * Absent onset of labor.\n * Patient acceptance to join the study after signing an informed consent.\n\nExclusion Criteria:\n\n* Placenta previa and or vasa previa.\n* Previous caesarean section(CS).\n* Multiple gestation\n* Any patient who will refuse to be a part of the study.\n* Intra- uterine fetal death (IUFD).'}, 'identificationModule': {'nctId': 'NCT02788305', 'briefTitle': 'Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy', 'orgStudyIdInfo': {'id': '9898'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non obese', 'description': 'BMI\\<30. Misoprostol is given for induction of labour according to Bishop score', 'interventionNames': ['Drug: Misoprostol']}, {'label': 'obese', 'description': 'BMI\\>30. Misoprostol is given for induction of labour according to Bishop score', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'description': 'Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups', 'armGroupLabels': ['non obese', 'obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11956', 'city': 'Cairo', 'state': 'Greater Cairo', 'country': 'Egypt', 'facility': 'Kasr wl aini hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Heba M Marie, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KasrElaini Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer at kaselaini hospitals', 'investigatorFullName': 'heba mahmoud ibrahim marie', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}