[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100303649":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":71,"collaborators":12,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":12,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":12,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":12,"overallStatus":37,"whyStopped":12,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Dose Oxytocin","NO_INTERVENTION","Patients randomized to the standard dose oxytocin will have their oxytocin infusion maintained at the standard of care protocol prior to placement of a combined spinal epidural for labor analgesia",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Half Dose Oxytocin","EXPERIMENTAL","Patients randomized to the half dose oxytocin will have their oxytocin infusion reduced by 50 % prior to placement of a combined spinal epidural for labor analgesia.",[18],"Drug: Half dose Oxytocin",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Half dose Oxytocin","Patients randomized to the half dose oxytocin group will have the oxytocin infusion reduced to 50 % prior to placement of combined spinal epidural for labor analgesia",[14],[26],{"name":27,"affiliation":5,"role":28},"Unyime Ituk","STUDY_DIRECTOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","319-356-2633","unyime-ituk@uiowa.edu",[35,56],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Iowa Hospitals and Clinics","RECRUITING","Iowa City","Iowa","52245","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-91.53017,41.66113,{"lat":47,"lon":46},[50,52],{"name":51,"role":31,"phone":32,"phoneExt":12,"email":33},"Unyime Ituk, MD",{"name":53,"role":31,"phone":54,"phoneExt":12,"email":55},"Zita A Sibenaller, PhD","319-356-8878","zita-sibenaller@uiowa.edu",{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":41,"countryCode":42,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Medical College of Wisconsin","NOT_YET_RECRUITING","Milwaukee","Wisconsin","53226",{"type":44,"coordinates":63},[64,65],-87.90647,43.0389,{"lat":65,"lon":64},[68],{"name":69,"role":31,"phone":12,"phoneExt":12,"email":70},"Meredith Albrecht, MD","maaalbrecht@mcw.edu",{"type":72,"investigatorFullName":27,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Associate Professor","100303649","phase-4-oxytocin-and-fetal-heart-rate-changes-100303649",false,"NCT03232918","Oxytocin and Fetal Heart Rate Changes","A Randomized Controlled Trial Evaluating the Effect of the Oxytocin Infusion Rate on Fetal Heart Rate Changes and Maternal-Fetal Outcomes During the Initiation of Combined Spinal-Epidural Labor Analgesia","Inclusion Criteria:\n\n* Healthy nulliparous or multiparous women at term (37 \\> weeks' gestation)\n* Singleton pregnancy\n* Request for neuraxial analgesia\n* Oxytocin used for induction of labor or augmentation of labor per institutional protocols\n\nExclusion Criteria:\n\n* Use of chronic analgesic medications\n* Prior administration of systemic opioid labor analgesia\n* Non-vertex presentation\n* Contraindication to neuraxial analgesia\n* Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia",true,"FEMALE","18 Years","55 Years",{"count":86,"type":87},730,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a reduction in the incidence of adverse fetal heart rate changes.",[93,94,95],"Fetal Bradycardia Complicating Labor and Delivery","Fetal Bradycardia During Labor","Fetal Heart Rate or Rhythm Abnormality Affecting Fetus","2025-05-30",{"date":98,"type":99},"2025-06-04","ACTUAL",{"date":101,"type":99},"2019-02-20",{"date":103,"type":87},"2025-12-31",{"name":27,"class":6},2]