[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582249":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":41,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients in Labor",null,"The study aims to recruit 200 patients in spontaneous or induced labor at 37-42 weeks of gestation, requesting the epidural labor analgesia (ELA) and meeting the inclusion criteria.",[13],"Procedure: Epidural Analgesia",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Epidural Analgesia","The eligible patients will have their vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery measured directly before the administration of ELA. They will be also asked to rate their level of pain on the visual analogue scale (VAS).\n\nThe specific method and drug regimen for ELA will be determined by the attending anesthesiologist. The mode of administration (continuous infusion, intermittent bolus, or patient-controlled epidural analgesia) will be recorded along with the anesthetic agents used for future subgroup analysis.\n\nThe vital signs, the Doppler velocities and VAS score will be recorded after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Joanna W Król, MD","CONTACT","+48 601 780 625","krol.joann@gmail.com",[27],{"facility":28,"status":10,"city":29,"state":10,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration","Warsaw","02-507","Poland","PL",{"type":34,"coordinates":35},"Point",[36,37],21.01178,52.22977,{"lat":37,"lon":36},[40],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Król Joanna","Principal Investigator","100582249","epidurals-impact-on-contractions-and-fetal-response-100582249",false,"NCT06860854","EPidural's Impact on Contractions and Fetal REsponse","The Effect of Epidural Analgesia on Uterine Contractility and Intrapartum Fetal Well-being - Study Protocol for a Prospective Observational Study \"EPI-CARE\"","EPI-CARE","Inclusion Criteria:\n\n* ≥ 18 years old\n* singleton pregnancy\n* signed informed consent form\n* patients in labor\n* cervical dilation ≥ 3cm,\n* patient requesting and eligible for epidural analgesia\n* normal CTG trace for at least 30 minutes before epidural analgesia\n\nExclusion Criteria:\n\n* \\\u003C than 18 years old\n* preterm delivery\n* labor induced or stimulated by oxytocin\n* multiple pregnancy\n* fetal malformations\n* \\\u003C than 3cm cervical dilation\n* lack of CTG trace for at least 30 minutes before epidural analgesia\n* patient not requesting or not eligible for epidural analgesia\n* informed consent form not signed","FEMALE","18 Years",{"count":56,"type":57},200,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to assess the impact of epidural analgesia (ELA) on uterine contractility, cardiotocography (CTG) patterns, and maternal-fetal hemodynamics in term pregnancies. The study will recruit 200 laboring patient receiving ELA and evaluate changes in uterine contractions, Doppler blood flow parameters, and fetal heart rate tracings before and after ELA administration. Secondary analyses will compare outcomes between primiparous and multiparous women, as well as between uncomplicated and complicated pregnancies. Pain relief effectiveness will be correlated with observed changes. This study will provide a comprehensive understanding of ELA's effects on labor progression and fetal well-being, addressing gaps in existing research.",[61,62,63],"Epidural Anesthesia in Labor and Delivery","Doppler Ultrasound","Uterine Contraction",[17,65,66,67],"Uterine Contractility","Maternal-Fetal Hemodynamics","Cardiotocography (CTG) Patterns","NOT_YET_RECRUITING","2025-02-28",{"date":71,"type":72},"2025-03-06","ACTUAL",{"date":74,"type":57},"2025-03-17",{"date":76,"type":57},"2025-12-31",{"name":5,"class":6},1]