Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT03570294
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'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': 'C047046', 'term': 'atosiban'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-06-25', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay preterm delivery for 48 hours', 'timeFrame': '48 hours', 'description': 'Delay preterm delivery for 48 hours, thus allowing administration of corticosteroids to induce surfactant production in fetal lungs and improve neonatal outcome'}], 'secondaryOutcomes': [{'measure': 'Apgar score', 'timeFrame': 'At birth', 'description': 'Apgar score'}, {'measure': 'Weight', 'timeFrame': 'At birth', 'description': 'Weight'}, {'measure': 'Incidence of duration of hospitalization', 'timeFrame': 'Up to 28 days after birth', 'description': 'Incidence of duration of hospitalization'}, {'measure': 'Time to delivery measured from start of Atosiban administration', 'timeFrame': 'Up to 15 weeks from start of Atosiban administration', 'description': 'Time to delivery measured from start of Atosiban administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '30622667', 'type': 'DERIVED', 'citation': 'Grzesiak M, Gaj Z, Kocylowski R, Suliburska J, Oszukowski P, Horzelski W, von Kaisenberg C, Banach M. Oxidative Stress in Women Treated with Atosiban for Impending Preterm Birth. Oxid Med Cell Longev. 2018 Dec 2;2018:3919106. doi: 10.1155/2018/3919106. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Oxidative stress is recognized as a important factor in the pathogenesis premature birth. Preterm birth is defined as delivery before 37 completed weeks of gestation and it is the leading cause of neonatal morbidity and mortality. The investigators conducted this analysis to investigate the safety of administration of Atosiban - a reversible, competitive antagonist of the oxytocin receptor in the treatment of preterm labor and its impact on the level of oxidative stress after 48 hours of tocolytic treatment.', 'detailedDescription': 'Atosiban (1-(3-mercaptopropanoic acid)-2-(O-ethyl-D-tyrosine)-4-L-threonine-8-L-ornithine-oxytocin) is licensed for clinical use in women suffering from threatened premature birth and is widely used in clinical practice in Europe because of its low side effect profile. The impact of Atosiban on pregnancy outcomes in women has been investigated in recent years and the research has shown its ability to reduce intracytoplasmic calcium release and downregulate prostaglandin synthesis as oxytocin receptor antagonist. While a role of Atosiban in the modulation of myometrial contractility is well-described, its effect on many other functions is not so well known.\n\nThe serum and plasma samples take for the measurement of total oxidant status (TOS), total antioxidant status (TAS), level of 3-nitrotyrosine (3-NT), and carbonyl and thiol groups will be stored at -70°C in aliquots for subsequent biochemical analysis and processed within two months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* pregnant women between 24-35 weeks' gestation receiving prenatal care due to the risk of premature birth\n* intact membranes\n* evidence of premature labor (regular, painful and persistent uterine contractions; cervical changes)\n\nExclusion Criteria:\n\n* acute fetal distress\n* other conditions requiring immediate delivery (eclampsia and severe pre-eclampsia, placenta previa, abruptio placenta)\n* vaginal bleeding,\n* premature rupture of membranes\n* chorioamnionitis,\n* fetal congenital malformations,\n* intrauterine growth restriction,\n* the use of any tocolytic drugs during pregnancy before admission to the hospital\n* circulatory system diseases (e.g. heart defects, hypertension),\n* symptoms of infection\n* other diseases that may increase oxidative stress"}, 'identificationModule': {'nctId': 'NCT03570294', 'briefTitle': 'Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth', 'organization': {'class': 'OTHER', 'fullName': 'Polish Mother Memorial Hospital Research Institute'}, 'officialTitle': 'Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban', 'orgStudyIdInfo': {'id': '2015/I/17-GW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Atosiban', 'description': 'Total oxidant status (TOS), total antioxidant status (TAS) and oxidative stress index (OSI) values as well as 3-nitrotyrosine, carbonyl and thiol groups levels weill be measure using ELISA test in serum and plasma of 64 pregnant women before and after 48 hours of continuous administration of Atosiban.', 'interventionNames': ['Drug: Atosiban']}], 'interventions': [{'name': 'Atosiban', 'type': 'DRUG', 'otherNames': ['Tractocile'], 'description': 'The initial dose of Atosiban (Tractocile, Ferring Pharmaceuticals A/S, Copenhagen, Denmark) will be give as a single intravenous bolus dose (6.75 mg in 0.9 ml isotonic sodium chloride solution). This will be follow immediately by intravenous infusion of 300 μg/min of Atosiban in 5% glucose for 3 hours, and then 100 μg/min for up to 48 hours. Venous blood samples from a forearm vein will take before and after 48 hours of continuous administration tocolytic therapy with Atosiban.', 'armGroupLabels': ['Atosiban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'facility': "Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute", 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Mariusz Grzesiak, Ph.D. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Obstetrics, Perinatology and Gynecology, Polish Mother's Memorial Hospital-Research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Study protocol, statistical analysis plan, informed consent form, clinical study report'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polish Mother Memorial Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}