Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-29 @ 1:41 PM
Study NCT ID:
NCT02691559
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D059245', 'term': 'Transient Tachypnea of the Newborn'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D059246', 'term': 'Tachypnea'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.', 'timeFrame': 'through study completion, an average of 8 months', 'description': 'Amniotic fluid will be analysed for the value of its pH'}, {'measure': 'A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.', 'timeFrame': 'through study completion, an average of 8 months', 'description': 'Amniotic fluid will be analysed for the value of its contents of electrolytes such as sodium, potassium, chlorid.'}], 'secondaryOutcomes': [{'measure': 'A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.', 'timeFrame': 'through study completion, an average of 8 months', 'description': 'Amniotic fluid will be analyzed for primary outcome measures by conventional methods and devices.'}]}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome', 'Transient Tachypnea of Newborn', 'Intrauterine Growth Retardation']}, 'descriptionModule': {'briefSummary': 'Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as PPROM, prematurity or fetal distress. It is known that fetal urine is the major content of AF since 20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract, umbilical cord and fetal side of placenta are important sources for AF. Bombesin-like peptides, 8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin, sphingomyelin, lamellar body in FAF are molecules acting on fetal lung maturation. Varying levels of these molecules relevant to the stage of lung maturation may constitute an association to AF pHTo detect the possible effect of AF pH on neonatal respiratory morbidities 1 milliliters of AF is aspirated during C-section before incision of membranes. pH value of AFs were analyzed by the blood gas machine (Siemens RAPIDLab®1200 Systems) of NICU. Maternal and neonatal demographic features and clinical outcomes, incidences of morbidities such as respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN) are all recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Minutes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInflammation/infection associated pregnancies Normal healthy pregnancies\n\nExclusion Criteria:\n\nCongenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid'}, 'identificationModule': {'nctId': 'NCT02691559', 'briefTitle': 'The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'maternal inflammation group', 'description': 'Amniotic fluid analysis by blood gas device: evaluate the possible association between maternal inflammation and amniotic fluid pH two groups will be designed. One group will consist of infants born to mothers with infection/inflammation whereas the control group will consist of infants born to mothers without infection/inflammation. In all deliveries amniotic fluid will be taken and will be analyzed by blood gas device.', 'interventionNames': ['Device: Amniotic fluid analysis by blood gas device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal pregnancy group', 'description': 'Amniotic fluid analysis by blood gas device: The control group will consist of infants born to mothers without infection/inflammation. In all deliveries amniotic fluid will be taken and will be analyzed by blood gas device.', 'interventionNames': ['Device: Amniotic fluid analysis by blood gas device']}], 'interventions': [{'name': 'Amniotic fluid analysis by blood gas device', 'type': 'DEVICE', 'description': 'Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group', 'armGroupLabels': ['maternal inflammation group', 'normal pregnancy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Seda Yilmaz Semerci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Postdoctoral Fellow of Neonatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellowship of Neonatology', 'investigatorFullName': 'Seda Yilmaz Semerci', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}