Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT06096805
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'maternal blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Present of maternal-vascular-malperfusion (MVM)-FGR', 'timeFrame': 'during the pregnancy, up to an average gestational age of 40 weeks', 'description': 'Development of MVM Fetal growth restriction'}], 'secondaryOutcomes': [{'measure': 'Other adverse pregnancy outcome', 'timeFrame': 'pregnancy-born after 28 days', 'description': 'including miscarriage, preeclampsia; intrauterine fetal death'}, {'measure': 'GA at delivery, birth weight, neonatal outcomes.', 'timeFrame': 'the day at birth', 'description': 'GA at delivery, birth weight, neonatal outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Growth Retardation']}, 'descriptionModule': {'briefSummary': 'This study intends to prospectively enroll high-risk pregnant women to establish a multicenter cohort. By combining maternal basic characteristics, medical history, early pregnancy ultrasound, and biological markers, we aim to construct a joint predictive model for MVM-FGR.', 'detailedDescription': 'Clinical guidelines do not recommend clinical screening for MVM-FGR in low-risk populations. Predictive models for FGR are often based on preeclampsia prediction models or Down syndrome serum screening models, which have limited utility. This study aims to establish a multi-center prospective cohort of pregnant women at high risk for FGR. We will collect baseline characteristics of pregnant women, ultrasound measurements of fetal growth, structural scans, maternal-fetal Doppler blood flow, as well as maternal serum and plasma in first and mid-trimester. Serum and plasma biomarker testing will be conducted. We will regularly observe fetal growth data, maternal-fetal complications during pregnancy, and collect delivery information, conditions of the newborn and placental pathology results after birth. By integrating maternal medical history, serum and plasma biomarkers, Doppler ultrasound, and other factors, we will establish a combined predictive model for early and mid-term MVM-FGR.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'First trimester pregnancy women who are at higher risk of fetal growth restriction.', 'genderDescription': 'First trimester pregnancy women who are at higher risk of fetal growth restriction.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with gestational age of \\<14 weeks\n* Maternal age between 18 and 45 years old\n* With at least one of FGR high risk factors:\n\n 1. Maternal age \\>40 years\n 2. Nulliparous, Maternal age \\>38 years\n 3. Previous pregnancy with FGR, PE or placental abruption\n 4. Maternal medical history of chronic hypertension, diabetes mellitus, chronic nephritis or autoimmune diseases (such as SLE or APS)\n 5. Recurrent spontaneous abortion (RSA) \\> 3 times with unknown causes\n* Or with at least two of the following FGR high risk factors:\n\n 1. Maternal age 35\\~40 years\n 2. BMI ≥ 28 kg/m2 or BMI \\< 18.5 kg/m2\n 3. Conception with assisted reproductive technology\n 4. Interval from previous delivery: \\> 5 years or \\< 6 months\n\n Exclusion Criteria:\n* Presence of fetal genetic abnormalities or severe structural abnormalities in prenatal ultrasound or genetic testing.'}, 'identificationModule': {'nctId': 'NCT06096805', 'briefTitle': 'Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR)', 'orgStudyIdInfo': {'id': 'ShanghaiFMIH-FMU7'}}, 'contactsLocationsModule': {'locations': [{'zip': '201204', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Luming Sun, Ph', 'role': 'CONTACT', 'email': 'luming_sun@163.com', 'phone': '021-20261151'}], 'facility': 'Shanghai First Maternity and Infant Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jianping Chen, Master', 'role': 'CONTACT', 'email': 'urchin_chen@163.com', 'phone': '13916159565', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Luming Sun, Docter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai First Maternity and Infant Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Luming Sun', 'investigatorAffiliation': 'Shanghai First Maternity and Infant Hospital'}}}}