Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-30 @ 9:51 AM
Study NCT ID:
NCT07119034
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Oxidative Stress Contents in Jordanian Pregnant Women With Preeclampsia
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Blood samples were collected from the antecubital vein and processed at the TrueLab medical laboratory. The whole blood was initially collected in plain tubes, and subsequently centrifuged to obtain serum samples. Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) levels were measured. The remaining serum samples were stored at -80°C until analysis at AAU's clinical laboratory, utilizing Enzyme-linked immunosorbent assay (ELISA) for Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde levels were measured using a colorimetric assay."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'targetDuration': '7 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Preeclampsia parameters', 'timeFrame': '7 months', 'description': 'Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)'}], 'primaryOutcomes': [{'measure': 'Oxadative stress parameters', 'timeFrame': '7 months', 'description': 'Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde'}, {'measure': 'Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde', 'timeFrame': '7 months', 'description': 'Thioredoxin and 4-Hydroxynonenal quantification, while malondialdehyde'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia (PE)', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Preeclampsia, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic compared to healthy pregnant women', 'detailedDescription': 'Preeclampsia, a widespread complication affecting pregnant women globally, necessitates a thorough investigation into the role of oxidative stress in its manifestation. This study aimed to assess the oxidative stress markers-malondialdehyde (MDA), 4-hydroxynonenal (4-HNE), and thioredoxin (Trx) in preeclamptic compared to healthy pregnant women.\n\nMethods: Ethical approval was obtained from Al-Ahliyya Amman University prior to starting the study. A total of 90 participants (45 preeclamptic pregnant women and 45 healthy pregnant women) were included in this study. Serum levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were measured by HUMAN200 auto analyzer (Germany) using a homogeneous enzymatic colorimetric assay. A kit from GenoChem world was used to measure the MDA levels via a colorimetric analysis technique Sandwich enzyme-linked immunosorbent assay (ELISA) was used to determine the serum levels of Trx and 4-HNE.\n\nResults: The results revealed significantly elevated levels of MDA and 4-HNE in preeclamptic women compared to their healthy counterparts (P\\<0.001). Although Trx levels did not differ significantly (P=0.29), marked distinctions were observed in LDL-C, TC, HDL-C, systolic and diastolic blood pressure (P\\<0.001). Preeclamptic women exhibited substantially higher LDL, TC, and blood pressure, and lower HDL.\n\nConclusion: This study highlights the correlation between elevated oxidative stress markers and an elevated risk of preeclampsia in pregnant women, which may suggest the impact of these markers in the pathogenesis of preeclampsia. These findings underscore the need for a nuanced understanding of these markers to enhance prenatal care and facilitate targeted interventions'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '45 with preeclampsia who completed the questionnaire, providing all necessary data', 'genderDescription': 'The study population, comprising preeclamptic and healthy pregnant women, was meticulously defined using anthropometric questionnaires and consideration of relevant medical features', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria specified pregnant women aged 20 to 40, diagnosed with preeclampsia based on blood pressure and proteinuria\n\nExclusion Criteria:\n\n* applied to those with diabetes, liver or kidney diseases, cardiovascular diseases, or using specific supplements like vitamins A, C, and E.'}, 'identificationModule': {'nctId': 'NCT07119034', 'acronym': 'Preeclampsia', 'briefTitle': 'Assessment of Oxidative Stress Contents in Jordanian Pregnant Women With Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Assessment of Oxidative Stress Parameters in Jordanian Pregnant Women With Preeclampsia', 'orgStudyIdInfo': {'id': 'Al-Ahliyya Amman University'}, 'secondaryIdInfos': [{'id': 'Preeclsmpsia', 'type': 'REGISTRY', 'domain': 'Al-Ahliyya Amman University'}, {'id': 'Preeclampsia', 'type': 'OTHER', 'domain': 'Al-Ahliyya Amman University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'control group comprising 45 healthy pregnant women', 'interventionNames': ['Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)']}, {'label': 'Preeclampsia group', 'description': 'Preeclampsia group 45 women with preeclampsia', 'interventionNames': ['Diagnostic Test: Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)']}], 'interventions': [{'name': 'Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples were collected from the antecubital vein and processed at the TrueLab medical laboratory. The whole blood was initially collected in plain tubes, and subsequently centrifuged to obtain serum samples. Total cholesterol (TC), random blood glucose (RBG), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) Thioredoxin and 4-Hydroxynonenal quantification, malondialdehyde levels', 'armGroupLabels': ['Control group', 'Preeclampsia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19328', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Al-Ahliyya Amman University', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Doaa El-Bohy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Ahliyya Amman University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Consent forms'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Ahliyya Amman University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of clinical Pharmacy', 'investigatorFullName': 'Doaa Mohamed Salah ElDin Diab ELBohy', 'investigatorAffiliation': 'Al-Ahliyya Amman University'}}}}