Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05105893
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2021-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Date Fruit Consumption in Later Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-04-18', 'releaseDate': '2022-02-10'}], 'estimatedResultsFirstSubmitDate': '2022-02-10'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-24', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-24', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of date fruit consumption in later pregnancy on length of gestation', 'timeFrame': '6 months', 'description': 'Effect of Intake of dates in later pregnancy on the period of gestation in weeks'}, {'measure': 'Effect of date fruit consumption in later pregnancy on labour and delivery', 'timeFrame': '6 months', 'description': 'To know the effect of dates intake on onset of labour whether it enhances the spontaneous onset of labour, avoiding any induction of labour and the time of 1st and 2nd stage of labour (in hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dates', 'labour', 'period of gestation', 'delivery'], 'conditions': ['Labor Long']}, 'descriptionModule': {'briefSummary': 'EFFECT OF DATE FRUIT CONSUMPTION IN LATER PREGNANCY ON LENGTH OF GESTATION LABOR AND DELIVERY OF NULLIPAROUS WOMEN', 'detailedDescription': "This randomized, controlled study was conducted at the Gynecology and Obstetrics department of Pak Emirates Military Hospital for Six months duration from Jan 2021 to June 2021. Ethical consent for the study was taken from the Ethical Committee. All participants have signed the written consent. Healthy primigravida's at more than 37 weeks of gestation with no prenatal complications (low-risk pregnancies) or chronic diseases were invited to contribute in the analysis.\n\nThe criteria of exclusion included all primigravida and non-primigravida with prenatal problems. Prenatal complications included placenta praevia, rupture of membranes, multiple pregnancies, diabetes, hypertension and additional health problems, fetal abnormalities, fetal growth restriction or any contraindication to delivery by vagina.\n\nThe females who met the eligibility criteria were contacted and provided information related to the analysis. In the preliminary phase of contact with potential volunteers, the study was presented as a participant's usage of dates to expedite delivery. The randomization arrangement was performed by means of sealed envelopes numbered from 1 to 10, equally allocated by randomization to the date-consumers and the group of control. Therefore, they will be allocated to dates consumer or control group recipients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All pregnant females at 37 weeks gestation or more with no complications', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All primigravidas at 37 or more weeks gestation with low risk pregnancies\n\nExclusion Criteria:\n\n* Any antenatal complications Preterm pregnancies'}, 'identificationModule': {'nctId': 'NCT05105893', 'briefTitle': 'Effect of Date Fruit Consumption in Later Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Pak Emirates Military Hospital'}, 'officialTitle': 'Effect of Date Fruit Consumption in Later Pregnancy on Length of Gestation Labor and Delivery of Nulliparous Women', 'orgStudyIdInfo': {'id': '13102021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dates group', 'description': 'The experimental group of women was given several dates orally and instructed to take seven a day and record their consumption until the beginning of the active phase of labor. Seven pieces of dates are about 80g of daily consumption', 'interventionNames': ['Other: Dates group']}, {'type': 'OTHER', 'label': 'No dates', 'description': 'This group wasnt provided dates.', 'interventionNames': ['Other: Dates group']}], 'interventions': [{'name': 'Dates group', 'type': 'OTHER', 'description': 'Seven dates to be provided to patients', 'armGroupLabels': ['Dates group', 'No dates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'PEMH', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Salma Nisar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pak Emirates Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident OBGYN', 'investigatorFullName': 'Salma Nisar', 'investigatorAffiliation': 'Pak Emirates Military Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-02-10', 'type': 'RELEASE'}, {'date': '2022-04-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Salma Nisar, Resident OBGYN, Pak Emirates Military Hospital'}}}}