Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 4:45 AM
Study NCT ID:
NCT05924061
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Pentraxin 3 and Cathepsin B Levels in Preeclamptic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002401', 'term': 'Cathepsin B'}], 'ancestors': [{'id': 'D002403', 'term': 'Cathepsins'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003546', 'term': 'Cysteine Endopeptidases'}, {'id': 'D057056', 'term': 'Cysteine Proteases'}, {'id': 'D010450', 'term': 'Endopeptidases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-06-19', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the effects and composite results of cathepsin b and pentraxin 3 levels in pregnant women diagnosed with preeclampsia', 'timeFrame': '12 months', 'description': 'serum cathepsin b (nmoL pNA/mL) and serum pentraxin 3 (ng/ml) levels composite results on pregnant women diagnosed with preeclampsia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['second trimester', 'preeclampsia', 'pentraxin 3', 'Cathepsin B'], 'conditions': ['Pre-Eclampsia', 'Cathepsin B Level', 'Pentraxin 3 Level']}, 'descriptionModule': {'briefSummary': 'In this study, the investigator aim was to compare Cathepsin B and Pentraxin 3 levels measured from maternal serum of pregnant women diagnosed with preeclampsia in the second trimester, the effects of these levels on maternal/ fetal outcomes and the composite results of Cathepsin B and Pentraxin 3 levels alone or together and contribute to the literature in this area.', 'detailedDescription': 'This prospective case-control study was conducted between 1 January 2022 and 31 December 2022 at Bursa Yuksek Ihtisas Training and Research Hospital. The study was conducted with pregnant women between ages of 18-45 who were diagnosed with preeclampsia in the second trimester. This study was conducted with total 156 pregnant women. participants were grouped according to the presence of preeclampsia; Group1: Patients diagnosed with preeclampsia between 20-28 weeks (study group) (n:78) , Group 2: Healthy pregnant women between 20-28 weeks without a diagnosis of preeclampsia ( control group) (n:78) . As soon as preeclampsia is diagnosed and before any treatment was started, maternal serum samples were collected in the Cathepsin B and Pentraxin 3 kit in amounts suitable for the study. The samples obtained were kept in biochemistry laboratory at -80 degrees until the study was conducted. After all samples were collected, Cathepsin B and Pentraxin 3 values were measured by ELISA method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'singleton pregnancy white people socio-cultural differences were not considered', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy\n* Pregnant women diagnosed with preeclampsia between 20-28 weeks of gestation\n* Healthy pregnant women between 20-28 weeks of gestation who want to be involved in the study.\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Pregnant women who gave birth below 24 weeks of gestation\n* Pregnant women diagnosed with other hypertensive diseases of pregnancy other than preeclampsia ( gestational hypertension, chronic hypertension, superimposed hypertension)\n* Pregnant women with chromosomal or congenital anomalies in the fetus\n* Women with a known infective or autoimmune disease before pregnancy'}, 'identificationModule': {'nctId': 'NCT05924061', 'briefTitle': 'The Role of Pentraxin 3 and Cathepsin B Levels in Preeclamptic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}, 'officialTitle': 'The Role of Pentraxin 3 and Cathepsin B Levels in the Second Trimester in Predicting of Maternal and Fetal Results in Preeclamptic Pregnancy', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2021/09-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women with preeclampsia between 20-28 weeks (study group)', 'description': 'Maternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks pregnant women with preeclampsia', 'interventionNames': ['Other: Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women']}, {'label': 'Healthy pregnant women between 20-28 weeks ( control group)', 'description': 'Maternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks healthy pregnant women ( control group)', 'interventionNames': ['Other: Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women']}], 'interventions': [{'name': 'Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women', 'type': 'OTHER', 'description': 'The effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia', 'armGroupLabels': ['Healthy pregnant women between 20-28 weeks ( control group)', 'Pregnant women with preeclampsia between 20-28 weeks (study group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Nefise Nazlı YENIGUL', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D. Assistant Professor Department of Obstetrics and Gynecology', 'investigatorFullName': 'Nefise Nazlı YENIGUL', 'investigatorAffiliation': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}}}}