Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-04 @ 2:13 AM
Study NCT ID:
NCT06043804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulsatility index', 'timeFrame': 'it can be monitored for up to 12 weeks', 'description': 'Pulsatility index of the left and right main uterine arteries'}, {'measure': 'Resistive index', 'timeFrame': 'it can be monitored for up to 12 weeks', 'description': 'Resistive index of the left and right main uterine arteries'}, {'measure': 'Systolic-to-diastolic ratio', 'timeFrame': 'it can be monitored for up to 12 weeks', 'description': 'Systolic-to-diastolic ratio of the left and right main uterine arteries'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abnormal Uteroplacental Circulation']}, 'descriptionModule': {'briefSummary': 'Objective:To explore the study of Doppler ultrasound in first trimester pregnancies to measure the change of uterine artery blood flow in normal pregnancies and the prediction on abortion, which provides a certain reference for the change trend of uterine artery blood flow in normal first trimester pregnancies and the prediction of Doppler ultrasound measurement in abortion.\n\nMethod:Pregnant women who underwent natural conception and single birth prenatal examination in the Obstetrics Department of the Second Affiliated Hospital of Wenzhou Medical University from October 1, 2023 to December 31, 2025 were selected as the study population. Eligible women were preliminarily screened according to the inclusion conditions of the study objects, and basic information of women in each group was compared: Maternal age, gestational time, birth time, gestational week, abortion history, maternal BMI, maternal MAP, smoking status, serum HCG, subchorionic hematoma, fetal bradycardia, left and right uterine aorta pulse index (PI), resistance index (RI) and systolic/diastolic ratio (S/D), etc. To investigate the effect of Doppler ultrasonography on the measurement of uterine artery blood flow in normal pregnancy and the prediction of abortion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy pregnant women Group\n\nInclusion Criteria:\n\n1. Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;\n2. Complete maternal clinical data;\n\nExclusion Criteria:\n\n1. The level of chorionic gonadotropin (HCG) was static or decreased by ultrasonography;\n2. multiple pregnancy;\n3. Patients with congenital uterine malformations, uterine fibroids and any other uterine disease;\n4. Patients who have chronic diseases or are receiving chronic treatment.\n\nPregnant women with recurrent pregnancy loss Group\n\nInclusion Criteria:\n\n1. Intrauterine pregnancy sac and cardiac activity were confirmed by ultrasound examination at 6 weeks;\n2. Complete maternal clinical data;\n3. There has been a history of spontaneous abortion with the same sexual partner for two or more consecutive times;\n\nExclusion Criteria:\n\n1. The level of chorionic gonadotropin (HCG) was static or decreased by ultrasonography;\n2. multiple pregnancy;\n3. Patients with congenital uterine malformations, uterine fibroids and any other uterine disease;\n4. Patients who have chronic diseases or are receiving chronic treatment.'}, 'identificationModule': {'nctId': 'NCT06043804', 'briefTitle': 'Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Study on Doppler Ultrasound Measurement of Changes in Uterine Artery Blood Flow in Normal First Trimester Pregnancies and Its Prediction on Abortion', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2023-07-208'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy pregnant woman', 'description': 'healthy pregnant woman', 'interventionNames': ['Other: Doppler ultrasound measurement of changes in uterine artery blood flow']}, {'label': 'Pregnant women with recurrent pregnancy loss', 'description': 'Spontaneous abortion of three or more consecutive sexual partners', 'interventionNames': ['Other: Doppler ultrasound measurement of changes in uterine artery blood flow']}], 'interventions': [{'name': 'Doppler ultrasound measurement of changes in uterine artery blood flow', 'type': 'OTHER', 'description': 'Doppler ultrasound measurement of changes in uterine artery blood flow', 'armGroupLabels': ['Pregnant women with recurrent pregnancy loss', 'healthy pregnant woman']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}