[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"induced-birth\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:induced-birth":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100558155","papaverine-and-oxytocin-vs-oxytocin-alone-in-labor-induction-100558155",false,"NCT06547437","Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction","\"Evaluating the Effectiveness of Papaverine as an Adjunct to Oxytocin for Labor Induction: A Randomized Controlled Trial\"","Inclusion Criteria:\n\n* Women with a singleton pregnancy Over the age of 18 Term (between 37-42 weeks of gestation) A medical decision for labor induction using oxytocin. Cephalic presentation Viable fetus nulliparity\n\nExclusion Criteria:\n\n* parity \\>1\n* Twin pregnancy Women with a previous cesarean section Severe fetal anomalies Women with psychiatric disorders, including depression and schizophrenia. Contraindication to vaginal delivery Women unable to sign the consent form Women known to have SVT (supraventricular tachycardia). Women with a heart rate over 100 or arrhythmia Known sensitivity to any component of the drug Liver disease",true,"FEMALE","18 Years","50 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone",[28,29],"Induced; Birth","Labor Onset and Length Abnormalities","NOT_YET_RECRUITING","2024-09-10",{"date":33,"type":34},"2024-09-19","ACTUAL",{"date":36,"type":22},"2024-09",{"date":38,"type":22},"2025-12",{"name":40,"class":41},"Western Galilee Hospital-Nahariya","OTHER_GOV",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100494537","phase-3-saint-safe-induction-of-labor-trial-100494537","NCT05719467","SAINT: Safe Induction of Labor Trial","A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor","SAINT","Inclusion Criteria:\n\n1. Participant must be between 18 and 50 years of age at the time of signing the informed consent.\n2. Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation\n3. Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made\n4. Participants carrying a fetus in vertex position\n5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Elective cesarean section\n3. Spontaneous start of labor\n4. Known maternal intestinal stenosis, ileus or megacolon\n5. Persisting maternal tachycardia (heart rate \\> 130 beats per minute) \\>30 minutes continuously.\n6. Known maternal myasthenia gravis\n7. Persisting fetal tachycardia (fetal heart rate baseline \\> 170 beats per minute) \\>30 minutes continuously.\n8. Maternal hypersensitivity to any of the ingredients in IMP (butylscopolamine bromide, bicarbonate or sodium chloride)\n9. Women with heart disease who are under surveillance with heart rate monitoring during labor\n10. Known fetal heart disease or known fetal malformations in the gastrointestinal system\n11. Untreated maternal glaucoma\n12. Maternal electrolyte disturbance: severe hyponatremia, severe hypokalemia\n13. Maternal moderate\u002Fsevere kidney failure (stage III-V: glomerulus filtration rate \\\u003C59 ml\u002Fminute\u002F1.73m2 )\n14. Maternal elevated serum creatinine (\\>90umol\u002FL)\n15. Maternal elevated Alanine Aminotransferase (ALAT) \\>100 U\u002FL. Participation can still be considered for participants with ALAT \\>100 U\u002FL if explained by obstetric cholestasis or HELLP syndrome.",{"count":51,"type":22},3000,[53],"PHASE3","Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy.\n\nAt the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH \\\u003C 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery.\n\nGiven that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted.\n\nBicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events.\n\nThe rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.",[56,28,57],"Labor Complication","Pregnancy Related","RECRUITING","2024-04-02",{"date":61,"type":34},"2024-04-04",{"date":63,"type":34},"2023-01-03",{"date":65,"type":22},"2027-12-31",{"name":67,"class":68},"Oslo University Hospital","OTHER",5]