[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638216":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":25,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":96,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Kansas Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Patients randomized to the control group will follow standard induction of labor protocol, which may include, but is not limited to, misoprostol, Foley catheter, and synthetic oxytocin (Pitocin). In other words, their induction will be the same as if they were not enrolled in the study.",[13],"Other: induction of labor",{"label":15,"type":16,"description":17,"interventionNames":18},"Nipple Stimulation","EXPERIMENTAL","Patients randomized to the experimental group will undergo standard IOL protocol with the addition of nipple stimulation.\n\nAt the time when the labor and delivery team deems a patient suitable for Pitocin initiation, patients will begin using a Symphony PLUS® breast pump for nipple stimulation. The breast pump will be turned on and placed on one breast (around the nipple) for 15 minutes, alternating breasts every 15 minutes. The default pump vacuum settings will be utilized. Contraction pattern and pump settings will be assessed every 30 minutes and adjusted if needed to maintain uterine contractions at a rate between 3 and 5 contractions per 10 minutes averaged over 30 minutes. Patients will perform nipple stimulation for no greater and no less than 2 hours. They will then resume normal care.",[19],"Other: Electric breast pump for nipple stimulation",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Electric breast pump for nipple stimulation","Symphony PLUS® breast pump. What distinguishes this induction of labor nipple stimulation study is how we will be applying the nipple stimulation. Many other studies exist, but they apply the stimulation in an uneven or inconsistent manner. They often do not specify how they interpret active and latent labor. Our study will be using nipple stimulation only for 2 hours per experimental participant so that we can better quantify the effect that nipple stimulation has on the labor process.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"induction of labor","Patients randomized to the control group will follow standard induction of labor protocol, which may include, but is not limited to, misoprostol, Foley catheter, and synthetic oxytocin (Pitocin).",[9],[31,35],{"name":32,"affiliation":33,"role":34},"Brian Brost, MD","Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine","STUDY_CHAIR",{"name":36,"affiliation":37,"role":38},"Rachel DiTeresi, MD","Clerkship Director for Obstetrics and Gynecology Department at KUMC","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":25,"email":44},"Bethany Snyder","CONTACT","9135233650","bsnyder3@kumc.edu",{"name":36,"role":42,"phone":46,"phoneExt":25,"email":47},"913-588-6200","rditeresi@kumc.edu",[49],{"facility":5,"status":25,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Kansas City","Kansas","66103","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-94.62746,39.11417,{"lat":59,"lon":58},[62,64],{"name":63,"role":42,"phone":46,"phoneExt":25,"email":47},"Rachel Diteresi, MD",{"name":32,"role":42,"phone":65,"phoneExt":25,"email":66},"913-588-6259","bbrost@kumc.edu",{"type":38,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Rachel DiTeresi","Associate Professor, Obstetrics and Gynecology","100638216","is-nipple-stimulation-effective-for-inducing-labor-and-acceptable-to-patients-nurses-and-providers-100638216",false,"NCT07588529","Is Nipple Stimulation Effective for Inducing Labor and Acceptable to Patients, Nurses, and Providers?","Nipple Stimulation Acceptability for Induction of Labor","NSAIL","Inclusion Criteria:\n\nAll patients presenting to KUMC labor \\& delivery for IOL will be considered for this study.\n\nMaternal\n\n* ≥18 years old and ≤ 50 years old\n* ≥37wga and ≤ 42wga\n* Intact amniotic membranes\n* English speaking Fetal\n* Cephalic presentation\n\nExclusion Criteria:\n\nMaternal\n\n* Inability to give informed consent\n* History of cesarean delivery or uterine myomectomy\n* History of uterine rupture\n* Intrahepatic cholestasis of pregnancy\n* Maternal life-threatening conditions\n* Active HSV\n* Gestational hypertension, Preeclampsia (severe or w\u002Fo severe features), HELLP, chronic hypertension on medications\n\nPlacental\n\n* Placenta previa, vasa previa\n* Suspicion for abnormally adherent placenta\n* Chorioamnionitis\n* Placental abruption\n\nFetal\n\n* Multifetal gestation\n* category 2 or 3 fetal heart tracing upon presentation (does not include isolated variable deceleration)\n* EFW \\> 5000 grams in mother with diabetes\n* EFW \\> 4500 grams in mother without diabetes\n* Fetal demise\n* Fetal growth restriction \\\u003C10th centile\n* Any other contraindication for vaginal birth or anticipation of need for NICU for care of baby","FEMALE","18 Years","50 Years",{"count":82,"type":83},48,"ESTIMATED","INTERVENTIONAL",[86],"NA","In this study the investigators will be testing the use of the Symphony PLUS® breast pump for nipple stimulation. Typically, breast pumps are used to start breast milk production and collect breast milk in patients after delivering their baby. The device uses cup-shaped pieces called flanges that are placed over the patient's nipples and then a gentle vacuum or suction is applied. The mechanical effect of the suction on the nipple is thought to cause the release of a substance called oxytocin in one's body, which encourages labor and contractions to begin. Some reasons why nipple stimulation might be better than other induction of labor methods are that it allows the patient to have more control over their induction process, it uses the patient's own oxytocin instead of synthetic (or factory-produced) oxytocin, and it may shorten the time that it takes to deliver the baby.",[89,90],"Pregnancy","Induction of Labor",[92,93,94,95,27],"nipple stimulation","breast stimulation","induction","labor","NOT_YET_RECRUITING","2026-05-08",{"date":99,"type":100},"2026-05-14","ACTUAL",{"date":102,"type":83},"2026-07",{"date":104,"type":83},"2028-12",{"name":5,"class":6},1]