Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:42 AM
Study NCT ID:
NCT07371520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004899', 'term': 'Erythroblastosis, Fetal'}], '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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemolytic Disease of the Newborn（HDN）', 'timeFrame': 'within 72 hours after birth', 'description': 'All the following criteria must have been met for a diagnosis of HDN: (1) Blood group incompatibility between the mother and newborn; (2) hyperbilirubinemia with a positive direct antiglobulin test (DAT) result or hyperbilirubinemia with a negative DAT result and a positive elution testing result with high suspicion of a hemolytic condition such as anemia and/or reticulocytosis.'}], 'secondaryOutcomes': [{'measure': 'Anemia: hemoglobin', 'timeFrame': 'within 72 hours after birth', 'description': 'Hemoglobin Concentration in Peripheral Blood of Neonates'}, {'measure': 'Incidence of severe hyperbilirubinemia', 'timeFrame': '30 days', 'description': 'The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group'}]}, 'conditionsModule': {'conditions': ['Hemolytic Disease of the Newborn']}, 'descriptionModule': {'briefSummary': "This study adopted a single-center, prospective, observational study design. A consecutive cohort of pregnant and postpartum women who met the inclusion criteria was recruited from Shanghai First People's Hospital between January 2026 and December 2028. Quantitative hemorrhage detection was performed using residual clinical blood samples, and the diagnostic value of this detection for hemolytic disease of the newborn (HDN) was analyzed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Pregnant and postpartum women\n2. Newborn', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational Age: Singleton pregnant women with gestational age ≥ 20 weeks.\n* Clinical High-Risk Factors (meeting at least one of the following criteria):\n* Traumatic Factors: Abdominal trauma (e.g., traffic accident, fall), intrauterine fetal version, amniocentesis, chorionic villus sampling (CVS).\n* Obstetric Complications: Placental abruption, placenta previa, preeclampsia, unexplained antenatal hemorrhage, post-interventional therapy for twin-twin transfusion syndrome (TTTS).\n* Fetal Abnormalities: Fetal growth restriction (FGR), unexplained abnormal fetal heart rate monitoring, fetal hydrops, fetal anemia (elevated middle cerebral artery peak systolic velocity (MCA-PSV) detected by Doppler ultrasound).\n* High-Risk Population with Maternal-Fetal Blood Group Incompatibility: Maternal-fetal ABO or Rh-negative blood group incompatibility; positive result of the first-trimester antenatal antibody screening in pregnant women.\n\nExclusion Criteria:\n\n* Pregnant women complicated with severe hematological diseases (e.g., coagulation disorders, immune thrombocytopenic purpura) or autoimmune diseases.\n* Newborns who withdrew treatment for non-study-related reasons or were lost to follow-up after birth, resulting in missing outcome data.\n* Termination of pregnancy due to various causes.\n* Failure to complete the analysis due to unqualified core clinical data (e.g., quantitative hemorrhage test results, bilirubin levels) or unsatisfactory specimens (hemolysis, insufficient volume).'}, 'identificationModule': {'nctId': 'NCT07371520', 'briefTitle': 'Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn', 'orgStudyIdInfo': {'id': 'IIT2025-275'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fetomaternal hemorrhage (FMH) values ≥ 0.5%'}, {'label': 'Fetomaternal hemorrhage (FMH) value < 0.5%'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jun Zhang', 'role': 'CONTACT', 'email': '156088435@qq.com', 'phone': '+86-021-36126361'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Jun Zhang', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}