Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-27 @ 11:28 AM
Study NCT ID:
NCT02979834
Status:
COMPLETED
Last Update Posted:
2016-12-02
First Post:
2016-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
When Will I Feel The First Movements of My Baby?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 423}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2016-11-26', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'placental settlement via ultrasound', 'timeFrame': '5 minutes', 'description': 'Relationship between placental location obtained via sonography and fetal movement perception'}], 'secondaryOutcomes': [{'measure': 'maternal body mass index measurement', 'timeFrame': '3 minutes', 'description': 'Relationship between Maternal Body Mass Index calculated by dividing body weight to height and fetal movement perception'}, {'measure': 'maternal age', 'timeFrame': '1 minute', 'description': 'Relationship between Maternal age according to questionnaire and fetal movement perception'}, {'measure': 'parity', 'timeFrame': '1 minute', 'description': 'Relationship between Maternal parity according to questionnaire and fetal movement perception'}, {'measure': 'educational status', 'timeFrame': '1 minute', 'description': 'Relationship between maternal education status according to questionnaire and fetal movement perception'}, {'measure': 'smoking', 'timeFrame': '1 minute', 'description': 'Relationship between Maternal smoking according to questionnaire and fetal movement perception'}, {'measure': 'tea and coffee consumption', 'timeFrame': '1 minute', 'description': 'Relationship between maternal tea and coffee conception according to questionnaire and fetal movement perception'}, {'measure': 'fetal gender', 'timeFrame': '5 minutes', 'description': 'Relationship between fetal gender obtained via sonography and fetal movement perception'}, {'measure': 'regular pregnancy follow ups', 'timeFrame': '1 minute', 'description': 'Relationship between regular pregnancy follow ups recorded on patient record system and fetal movement perception'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fetal movement', 'placenta site', 'body mass index', 'maternal education'], 'conditions': ['Early Pregnancy']}, 'descriptionModule': {'briefSummary': "This study aims to investigate average gestational week in which mothers feel the babies'movements for the first time and maternal-fetal factors affecting this time.", 'detailedDescription': 'Most of the obstetricians face the question; "When Will I Feel The First Movements of My Baby?", in daily practice. It becomes a challenge for the obstetrician to answer this question. Because, there is not a sufficient data in the current literature on this issue. A broad range of weeks for fetal quickening are reported as 16th to 20th weeks, in round figures. So, when a woman in the 21st gestational week , asks this question to the obstetrician and informed according to aforementioned literature knowledge, the woman will ask another question immediately after: "What is the problem with my baby?". But, the obstetrician will not be able to give an assuring answer because of the lack of knowledge in the current literature.Thus, to cope with such a clinical situation, the investigators decided to investigate the average week in which pregnant women in a low risk population, felt the babies\' movements for the first time and to find out the affects of probable factors which may act on this time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Three groups were formed according to the gestational week in which fetal movements felt by mother for the first time. 25th percentile, 50thand 75th percentile values were determined .Participants who felt the babies' movements at or before 25th percentile value constituted Group1 or early perception group, participants who felt the babies' movements between 25th and 75th percentile value constituted Group 2 or average perception group and the participants who felt the babies'movements at or beyond 75th value constituted Group 3 or late perception group. Subsequently, these three groups were compared regarding maternal age, gestational week of inclusion in the study, obstetric features, maternal body mass index values, caffeine consumption, smoking status, maternal education status, placental localization and fetal gender.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study population included spontaneous, singleton pregnancies at first and second-trimester of their pregnancy\n\nExclusion Criteria:\n\n* Multiple pregnancies, evidence of fetal or maternal infection, hypertensive disorders of gestation, gestational and pregestational diabetes mellitus, maternal drug use, evidence of fetal congenital abnormalities and amniotic fluid abnormalities were stated as the exclusion criteria for the study group.'}, 'identificationModule': {'nctId': 'NCT02979834', 'acronym': 'FFM', 'briefTitle': 'When Will I Feel The First Movements of My Baby?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'officialTitle': 'A Frequently Asked Question: When Will I Feel The First Movements of My Baby?', 'orgStudyIdInfo': {'id': 'E52332816/53'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early perception group', 'description': 'The group with early perception of fetal movement (\\<25th percentile)'}, {'label': 'Average perception group', 'description': 'The group with average perception of fetal movement (\\>25th and \\<75th percentile)'}, {'label': 'Late perception group', 'description': 'The group which late perception of fetal movement (\\>75 percentile)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hatice Akkaya, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data belonging to participant will be available to any researcher or editorial review board if needed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Hatice Akkaya', 'investigatorAffiliation': 'Kayseri Education and Research Hospital'}}}}