Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT04248660
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2020-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Artery Doppler and 11-14 / 20-22 Weeks of Gestation Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2020-01-28', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Doppler results of 11-14 weeks of gestation in patients with previous cesarean section', 'timeFrame': '10 months', 'description': 'uterine artery doppler values (uterine artery PI , presence of uterine artery notch)'}, {'measure': 'Doppler results of 11-14 weeks of gestation in those who gave birth beforehand', 'timeFrame': '10 months', 'description': 'uterine artery doppler values (uterine artery PI , presence of uterine artery notch)'}, {'measure': 'Doppler results of 20-22 weeks of gestation in patients with previous cesarean section', 'timeFrame': '10 months', 'description': 'uterine artery doppler values (uterine artery PI , presence of uterine artery notch)'}, {'measure': 'Doppler results of 20-22 weeks of gestation in those who gave birth beforehand', 'timeFrame': '10 months', 'description': 'uterine artery doppler values (uterine artery PI , presence of uterine artery notch)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine artery doppler', 'type of delivery', 'obstetric outcomes'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Uterine artery doppler measurements will be made at 11-14 weeks and 20-22 weeks of gestation, and the classification of these measurements according to type of delivery; and to investigate the change in the effect of delivery type on uterine artery flows on obstetric outcomes (maternal, fetal, neonatal outcomes).', 'detailedDescription': 'The first and second trimester perinatal examination results performed by the same operator from pregnant women who have applied to the clinic since the first trimester are removed from the ViewPoint 6.0 server and database and their uterine artery doppler values (uterine artery PI and RI values, presence of uterine artery notch), placental location, gestational week of measurement, blood pressures, PAPP-A and hCG MoM values, obstetric results (type of birth, week, weight, ante-postpartum complications), data to be generated from other hospital records will be saved to the base'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had uterine artery doppler measurements and delivered at 11-14 weeks and 20-22 weeks of pregnancy will be the study group. these patients; Doppler results will be classified according to pregnancy results, and the classification of these measurements according to type of delivery; and the effect of delivery on uterine artery flows on obstetric outcomes (maternal, fetal, neonatal outcomes) will be examined.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 11-14. applying to the outpatient clinic at week\n* Single spontaneous pregnancy\n* Having a first pregnancy (primigravid nullipar) or having given birth once (primipar) (first birth by vaginal route or cesarean)\n* Result of previous pregnancy with live birth (term delivery without obstetric complication)\n* No intrauterine growth restriction in the first pregnancy\n* Women who gave birth by cesarean section were not placed due to caesarean indication due to placental location-invasion anomaly, maternal chronic disease (hypertension, diabetes, coronary artery disease, etc.), placental detachment.\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Pregnancies with assisted reproductive techniques\n* Placental anomaly in previous pregnancy\n* Maternal chronic hypertension, preeclampsia, history of diabetes\n* Pregnant women who smoke\n* The presence of fetal chromosomal or structural anomaly\n* two or more cesarean sections\n* Having undergone non-cesarean surgery (myomectomy, septum or polyp resection ... etc)\n* Presence of uterine structural anomaly'}, 'identificationModule': {'nctId': 'NCT04248660', 'briefTitle': 'Uterine Artery Doppler and 11-14 / 20-22 Weeks of Gestation Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison of Uterine Artery Doppler Measurements Performed at 11-14 and 20-22 Weeks of Gestation During Pregnancy According to Delivery Type and Number of Births and Investigation of the Effects on Obstetric Outcomes (Maternal, Fetal, Neonatal Results)', 'orgStudyIdInfo': {'id': 'ATADEK-2020/00'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uterine artery doppler measurements', 'description': 'Uterine artery doppler measurements will be made in the same patients at 11-14 weeks and 20-22 weeks of pregnancy.\n\nDoppler results will be classified according to pregnancy results and primary results will be doppler findings.', 'interventionNames': ['Other: uterine artery doppler measurement']}], 'interventions': [{'name': 'uterine artery doppler measurement', 'type': 'OTHER', 'description': 'The effect of delivery type on changes in uterine blood flow will be investigated.\n\nDoppler results groups will be defined according to the effect of deviations in uterine blood flow on neonatal and perinatal results.', 'armGroupLabels': ['Uterine artery doppler measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33404', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Pınar Kadirogulları', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}