[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445428":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University Hospital, Caen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","SHAM_COMPARATOR","During labor the women will have free access to water only but not fruit juice or other calory source.",[13],"Other: free water only",{"label":15,"type":16,"description":17,"interventionNames":18},"Carbohydrate","EXPERIMENTAL","During labor the women will have free access to water and 20 ml commercial fruit juice bricks containing between 430 or 660 kcal\u002Fl. Every 2 hours the midwife or the nurse will measure the fruit juice oral intake volume and will advise women to drink the planned volume (1 brick\u002F2hours)",[19],"Dietary Supplement: carbohydrate oral intake",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","carbohydrate oral intake",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"free water only","Women will have free access to water only",[9],[31],{"name":32,"affiliation":33,"role":34},"jean-luc hanouz, M.D., Ph.D.","University Hospital of Caen","STUDY_CHAIR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"jean-luc hanouz","CONTACT","33 2 31 06 47 36","hanouz-jl@chu-caen.fr",[42],{"facility":43,"status":44,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Caen University Hospital","RECRUITING","Caen","France","FR",{"type":49,"coordinates":50},"Point",[51,52],-0.35912,49.18585,{"lat":52,"lon":51},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100445428","effect-of-oral-carbohydrate-intake--44kcal-per-hour-during-labour-on-the-rate-of-instrumental-vaginal-delivery-100445428",false,"NCT05080309","Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery","soliso-2","Inclusion Criteria:\n\n* nulliparous women\n* singleton pregnancy\n* social insurance\n* uncomplicated pregnancy\n* no contraindication to vaginal delivery\n\nExclusion Criteria:\n\n* scheduled caesarean section\n* labor \\\u003C 37 weeks of gestational age\n* cervical dilation \\> 8cm at inclusion\n* scheduled induced delivery\n* contraindication to pushing effort during labor and delivery\n* BMI \\> 40 kg\u002Fm2\n* medical history of diabetes mellitus, hypertension, heart disease","FEMALE","18 Years","60 Years",{"count":67,"type":68},600,"ESTIMATED","INTERVENTIONAL",[71],"NA","Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate.\n\nIn a previous study we reported a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake during labour. However due to some limitations no clear conclusion could be drawn.\n\nThe present study is designed to examine the relationship between a high calory oral intake (\\>44 kCal\u002Fhour during labour) and the rate of instrumental delivery.",[74,75,76],"Delivery Complication","Labor Long","Pregnancy Related",[78,79,80,81],"labor","instrumental vaginal delivery","oral intake","nulliparous","2025-07-22",{"date":84,"type":85},"2025-07-25","ACTUAL",{"date":87,"type":85},"2022-02-11",{"date":89,"type":68},"2028-09-03",{"name":5,"class":6},1]