[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617650":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":91,"collaborators":94,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":25,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":134,"whyStopped":25,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Copenhagen University Hospital, Hvidovre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sodium bicarbonate","EXPERIMENTAL","Participants receive oral sodium bicarbonate 4.26 gram once.",[13],"Drug: Sodium bicarbonate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive placebo once.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","4,26 gram given once.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo given once.",[15],[30],{"name":31,"affiliation":32,"role":33},"Nanna Maaløe, PhD","University of Copenhagen","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Nanna Maaløe, PI, PhD","CONTACT","+4541271984","nannam@sund.ku.dk",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Nina Olsén Nathan, Co-PI, PhD","+4553670600","nina.olsen.nathan@regionh.dk",[45,67,80],{"facility":46,"status":25,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Aarhus University Hospital","Aarhus","8200","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],10.21076,56.15674,{"lat":55,"lon":54},[58,62,65],{"name":59,"role":37,"phone":60,"phoneExt":25,"email":61},"Monica L Kujabi, PhD","23862727","monica.kujabi@sund.ku.dk",{"name":63,"role":37,"phone":25,"phoneExt":25,"email":64},"Signe Hedegaard, MD","signe.hedegaard@regionh.dk",{"name":66,"role":33,"phone":25,"phoneExt":25,"email":25},"Julie Glavind, PhD",{"facility":5,"status":25,"city":68,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Copenhagen",{"type":52,"coordinates":70},[71,72],12.56553,55.67594,{"lat":72,"lon":71},[75,76,78],{"name":31,"role":37,"phone":25,"phoneExt":25,"email":39},{"name":77,"role":37,"phone":25,"phoneExt":25,"email":64},"Signe Hedegaard, PhD",{"name":79,"role":33,"phone":25,"phoneExt":25,"email":25},"Charlotte Holm, PhD",{"facility":81,"status":25,"city":68,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Copenhagen University Hospital, Rigshospitalet",{"type":52,"coordinates":83},[71,72],{"lat":72,"lon":71},[86,88,89],{"name":87,"role":37,"phone":25,"phoneExt":25,"email":43},"Nina Nathan, PhD",{"name":77,"role":37,"phone":25,"phoneExt":25,"email":64},{"name":90,"role":33,"phone":25,"phoneExt":25,"email":25},"Mona A Karlsen, PhD",{"type":33,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Nanna Maaløe","Associate Professor",[95,96,98,99,101,103],{"name":32,"class":6},{"name":97,"class":6},"Rigshospitalet, Denmark",{"name":46,"class":6},{"name":100,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research",{"name":102,"class":6},"University of Liverpool",{"name":104,"class":6},"University of Amsterdam","100617650","efficacy-of-bicarbonate-on-the-risk-of-assisted-delivery-in-nulliparous-women-with-prolonged-labour-100617650",false,"NCT07321379","Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour","Efficacy of Bicarbonate on the Risk of Assisted Delivery in Danish Nulliparous Women With Prolonged Labour: a Double-blinded Parallel Randomized Controlled Trial (The ProLabour Trial)","ProLabour","Inclusion Criteria:\n\n* Age ≥18 years.\n* Danish or English speaking.\n* Cephalic presentation.\n* Gestational age ≥34+0 - \\\u003C42+0 (days +weeks) at onset of labour.\n* Normal foetal heart rate pattern in the 20 minutes prior to inclusion.\n* Spontaneous onset of labour or non-medical induced labour (balloon catheter and\u002For artificial rupture of membranes).\n* Active first stage of labour confirmed, according to Danish national guidelines: Cervical dilatation at ≥4 - \\\u003C10 cm with regular painful contractions.\n* Prolonged labour diagnosed, according to Danish national guidelines: Cervical dilatation progresses at less than 2 cm over a 4-hour period.\n\nExclusion Criteria:\n\n* Clinical suspicion of infection (2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics initiated)\n* Significant medical comorbidity in the form of renal or heart condition, assessed case-by-case basis.\n* Serious obstetric complication\n* Known allergy or intolerance to sodium bicarbonate.\n* Ingestion of sodium bicarbonate in active labour prior to inclusion.\n* Current treatment with following medicines: Gabpabpentin, Tetracycline, Ketoconazole (NB! These medications are already generally advised contradicted against induring pregnancy)","FEMALE","18 Years","50 Years",{"count":117,"type":118},1520,"ESTIMATED","INTERVENTIONAL",[121],"NA","The goal of this clinical trial is to learn if oral bicarbonate can treat prolonged labour in nulliparous women with prolonged labour.\n\nThe main question it aims to answer is: Do oral bicarbonate and restrictive oxytocin use reduce assisted delivery rate (emergency cesarean and vacuum\u002Fforceps delivery) in nulliparous women with prolonged labour.\n\nResearchers will compare bicarbonate and placebo (a look-alike substance that contains no drug) to see if bicarbonate works to treat prolonged labour.\n\nParticipants will:\n\n* drink bicarbonate or placebo\n* have cervical dilatation reassessed after 2 hours. If still slow progression, they will follow standard protocol for oxytocin augmentation\n* will receive a questionnaire 1 month post partum to assess birth experience\n\n1\u002F3 of participants will have amniotic fluid lactate measured at inclusion and after 2 hours",[124,125],"Prolonged Labor","Labor Dystocia",[127,128,129,130,131,132,133],"Labor","Bicarbonate","Caesarean section","Assisted birth","Oxytocin","Labor augmentation","Intrapartum","NOT_YET_RECRUITING","2026-01-08",{"date":137,"type":138},"2026-01-12","ACTUAL",{"date":140,"type":118},"2026-02-01",{"date":142,"type":118},"2028-01-31",{"name":5,"class":6},3]