Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02635451
Status:
UNKNOWN
Last Update Posted:
2015-12-18
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2015-12-17', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relation between serum vitamin C concentration and PPROM', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vitamin c', 'Preterm Premature Rupture of Membranes'], 'conditions': ['Preterm Premature Rupture of Membranes']}, 'descriptionModule': {'briefSummary': 'To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.', 'detailedDescription': 'The micronutrient vitamin C is an effective water soluble antioxidant that scavenges several reactive oxygen species, thus reducing oxidative stress, It also acts as an enzymatic cofactor to the enzymes lysyl hydroxylase and prolyl hydroxylase, which is required for synthesis of hydroxyproline and hydroxylysine, Collagen requires hydroxyproline bridges across the triple helix to provide stability to it, Ascorbic acid also causes down regulation of the metalloproteinase-2 and biosynthesis of collagen where it is required for the formation of triple helical structure of collagen. Thus, ascorbic acid participates in the equilibrium between synthesis and degradation of collagen and this may be critical in reducing the occurrence of preterm PROM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital starting from January 2016.\n\nThis study will include 40 pregnant women between 28-37 weeks were recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies\n* Gestational age between 28-37 weeks\n* Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal\n\nExclusion Criteria:\n\n* Patients with multiple pregnancies\n* Smoker\n* Polyhydramnios\n* Maternal diseases such as: anemia, diabetes, UTI, RTI and vaginal infection\n* History of PPROM in previous pregnancies\n* Evidence of chorioamnionitis in current pregnancy'}, 'identificationModule': {'nctId': 'NCT02635451', 'briefTitle': 'The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes', 'orgStudyIdInfo': {'id': 'MHMostafa'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'Study group included 20 pregnant women with PPROM and fulfilled the inclusion and exclusion criteria.'}, {'label': 'control group', 'description': 'Control group also included 20 pregnant women without PPROM following every recorded case of PPROM and matched for gestational age.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Hu Mostafa, MD', 'role': 'CONTACT', 'email': 'magicmostwanted@yahoo.com', 'phone': '01003993165', 'phoneExt': '02'}, {'name': 'Mohamed Hu Mostafa, MD', 'role': 'CONTACT', 'email': 'magic2mostwanted@yahoo.com', 'phone': '01003993912', 'phoneExt': '02'}], 'overallOfficials': [{'name': 'Sherif M Habib, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Obstetric and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Obstetric and Gynecology', 'investigatorFullName': 'Mohamed Hussein Mostafa', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}