Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-28 @ 1:14 AM
Study NCT ID:
NCT05986357
Status:
UNKNOWN
Last Update Posted:
2023-08-14
First Post:
2023-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Highly sensitive CRP (HS-CRP)', 'timeFrame': '9 months', 'description': 'A high level of hs-CRP, i.e., greater than 3 mg/L,'}, {'measure': 'total leucocytic count', 'timeFrame': '9 months', 'description': 'measures the number of white blood cells (WBCs) in blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['C reactive protein', 'total and differential leucocytic count', 'abortion'], 'conditions': ['Abortion Early']}, 'descriptionModule': {'briefSummary': 'to identify the relation between maternal serum high sensitivity C reactive protein and total and differential leucocytic count values in healthy pregnant women with threatened abortion and the outcome of pregnancy', 'detailedDescription': 'observational prospective cohort research will be pregnant women attending to obstetrics and gynecology department of University Hospital. After enrollment, participants will be divided into two groups:\n\n* Study group: had 120 healthy women presenting with threatened miscarriage.\n* Control group: had 120 healthy women with an uncomplicated single pregnancy. informed permission will be obtained. All cases subjected to the following: taking complete history, General examination, Special investigations including Obstetric ultrasonography for assessment of gestational age, and exclusion of congenital anomalies or multi-fetal gestation. Laboratory investigations including Estimation of the complete blood picture (CBC), Highly sensitive CRP (HS-CRP) single measurement, Women over 1st trimester abdominal ultrasonographic examination (6-13weeks) using Toshiba with transabdominal transducer probe frequency of 7 MHz to evaluate the following data: Measuring of the fetal crown-rump length (CRL) done to confirm the fetal gestational age and the viability of the fetus. Gestational age will be calculated from the beginning of the last regular menstrual cycle. Women who had hormone therapy or progesterone supplements, as well as pregnancies with a discrepancy between LMP and crown rump length of more than three days, were excluded from the research.\n\nPregnant women will be under close follow up every 2 weeks by: Obstetric U/S, Measure blood pressure and inform us if severe bleeding occurs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study group, an ultrasound showing an intrauterine gestational sac with a live fetus and a regular fetal heartbeat, with/without a sub-chorionic hematoma, and healthy women who come for routine antenatal care with spontaneous pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study group,\n* an ultrasound showing an intrauterine gestational sac with a live fetus and a regular fetal heartbeat, with/without a sub-chorionic hematoma,\n* healthy women who come for routine antenatal care with spontaneous pregnancy.\n\nExclusion Criteria:\n\n* Age over 40\n* smoking\n* multiple pregnancies\n* endocrinological diseases\n* history of repeated spontaneous abortions.'}, 'identificationModule': {'nctId': 'NCT05986357', 'briefTitle': 'The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'The Relation Between Maternal Serum High Sensitivity C Reactive Protein and Total and Differential Leucocytic Count Levels in Healthy Pregnant Women With Threatened Abortion and the Outcome of Pregnancy', 'orgStudyIdInfo': {'id': 'C reactive protein abortion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': '120 healthy women presenting with threatened miscarriage.', 'interventionNames': ['Diagnostic Test: maternal serum C reactive protein', 'Diagnostic Test: total leucocytic count levels', 'Diagnostic Test: differential leucocytic count levels']}, {'label': 'Control group', 'description': '120 healthy women with an uncomplicated single pregnancy.', 'interventionNames': ['Diagnostic Test: maternal serum C reactive protein', 'Diagnostic Test: total leucocytic count levels', 'Diagnostic Test: differential leucocytic count levels']}], 'interventions': [{'name': 'maternal serum C reactive protein', 'type': 'DIAGNOSTIC_TEST', 'description': 'maternal serum high sensitivity C reactive protein', 'armGroupLabels': ['Control group', 'Study group']}, {'name': 'total leucocytic count levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'total leucocytic count levels', 'armGroupLabels': ['Control group', 'Study group']}, {'name': 'differential leucocytic count levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'differential leucocytic count levels', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62521', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'country': 'Egypt', 'facility': 'Beni-suef university Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Beni-suef University', 'role': 'CONTACT', 'email': 'fom@med.bsu.edu.eg', 'phone': '082 2318605', 'phoneExt': '02'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University', 'investigatorFullName': 'Sara Abdallah Mohamed Salem', 'investigatorAffiliation': 'Beni-Suef University'}}}}