Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 7:46 PM
Study NCT ID:
NCT04497532
Status:
UNKNOWN
Last Update Posted:
2021-03-04
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Diet on Pregnancy With Polyhydramnios
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006831', 'term': 'Polyhydramnios'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amniotic fluid index (AFI) after 2 weeks', 'timeFrame': 'Assess AFI two weeks after diet initiation', 'description': 'AFI as measured in ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polyhydramnios']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age\n* Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.\n* Without a medical indication for an immediate delivery\n\nExclusion Criteria:\n\n* Medical recommendation for delivery within two weeks of diagnosis\n* Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection\n* Premature rupture or membranes\n* Twins pregnancy'}, 'identificationModule': {'nctId': 'NCT04497532', 'briefTitle': 'Influence of Diet on Pregnancy With Polyhydramnios', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'The Influence of a Diet Suited for Gestational Diabetes on Amniotic Fluid Index in Patients Diagnosed With Idiopathic Polyhydramnios - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0152-19-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Diet', 'interventionNames': ['Other: Diet as suited for gestational diabetes mellitus']}], 'interventions': [{'name': 'Diet as suited for gestational diabetes mellitus', 'type': 'OTHER', 'description': 'Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.', 'armGroupLabels': ['Diet']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liliya Tamayev, MD', 'role': 'CONTACT', 'email': 't_liki@yahoo.com', 'phone': '+972532343882'}], 'overallOfficials': [{'name': 'Liliya Tamayev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wolfson Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Liliya Tamayev', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}