Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT06752161
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2024-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Infection in Pregnant Women with Urinary Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016482', 'term': 'Urinalysis'}], 'ancestors': [{'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2024-12-27', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percent of urinary tract infections in threatened preterm labor', 'timeFrame': '1 month', 'description': 'Percentage of women with threatened preterm labor diagnosed with urinary tract infection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['UTI', 'Preterm labour'], 'conditions': ['Threatened Preterm Labour']}, 'descriptionModule': {'briefSummary': 'Urine analysis and culture in patients with threatened preterm labour', 'detailedDescription': 'UTI is an infection of the kidneys, bladder, or urethra. Infectious cystitis is the most common type of UTI, which is caused by a bacterial infection of the bladder. Lifetime incidence of UTIs is 50% to 60% in adult women.UTIs are among the most common conditions encountered in primary care, hospitals, and extended care facilities . Total direct costs of UTI treatment (without cultures) have been estimated at US $25.5 billion annually.Despite an exceptionally high prevalence of bacteriuria in the population, these infections rarely cause significant renal damage.Sexual intercourse is the strongest risk factor. Any lifetime sexual activity and any sexual activity during the past year are strongly associated with recurrent UTI. Even the relatively small amounts of spermicide coating condoms increases the risk of UTI. Post-menopausal absence of oestrogen is a risk factor for UTIs. Topical oestrogen reduces UTIs in post-menopausal women; Oestrogenisation of the vaginal mucosa promotes lactobacilli colonisation, which reduces the presence of uropathogens and thus the risk of UTIs and is not recommended over the use of topical oestrogen therapy. Urinary incontinence and oestrogen supplementation have also been associated with UTI in older women, although the reasons for this are incompletely understood. positive family history of UTIs is associated with a two- to fourfold increase in risk of recurrent UTI . Bacteriuria occurs in the presence of indwelling or intermittent catheters, and asymptomatic bacteriuria does not require treatment. Gestational and pregestational diabetes are considered a more predominant risk factor in older women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with threatened preterm labor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with preterm labor\n\nExclusion Criteria:\n\n* renal disease Intrauterine fetal death'}, 'identificationModule': {'nctId': 'NCT06752161', 'briefTitle': 'Urinary Infection in Pregnant Women with Urinary Infection', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Urinary Tract Infections in Patients with Threatened Preterm Labor', 'orgStudyIdInfo': {'id': 'UTIP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women with threatened preterm labour', 'description': 'Patients with UTI and preterm labour', 'interventionNames': ['Other: Urine analysis']}], 'interventions': [{'name': 'Urine analysis', 'type': 'OTHER', 'description': 'Urine analysis and culture for Screening and diagnostic tools for UTI in pregnant women', 'armGroupLabels': ['Pregnant women with threatened preterm labour']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Women Hospital', 'role': 'CONTACT', 'email': 'ethics_committee12@yahoo.com', 'phone': '0882414916'}], 'facility': "Women's Health Hospital", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed Fekry, PhD', 'role': 'CONTACT', 'email': 'mohamedbeethoven2040@gmail.com', 'phone': '0882312388'}], 'overallOfficials': [{'name': 'Mohammed Seif al nasr, MBBCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women's Health Hospital Resident"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of obstetric and gynecology, specialist of Uro gynecology', 'investigatorFullName': 'Mohamed Gamal M.fekry', 'investigatorAffiliation': 'Assiut University'}}}}