[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602486":3},{"organization":4,"outcomesModule":7,"designInfo":145,"detailedDescription":11,"studyPopulation":11,"armGroups":153,"interventions":165,"overallOfficials":11,"centralContacts":175,"locations":181,"responsibleParty":208,"collaborators":211,"id":214,"slug":11,"hasResults":215,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":11,"eligibilityCriteria":219,"healthyVolunteers":215,"sex":220,"minAge":221,"maxAge":11,"enrollmentInfo":222,"targetDuration":11,"studyType":225,"phases":226,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":184,"whyStopped":11,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"Eastern Virginia Medical School","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Time from Induction Start To Delivery",null,"From enrollment to the end of labor",[14,18,22,25,29,33,37,40,44,48,52,55,58,61,64,67,70,74,78,82,86,89,92,95,99,103,107,110,113,117,120,124,128,131,134,138,141],{"measure":15,"description":16,"timeFrame":17},"Type of amniotomy","Spontaneous vs artificial","From enrollment until delivery",{"measure":19,"description":20,"timeFrame":21},"Mode of Delivery","The incidence of spontaneous vaginal delivery, operative vaginal delivery and cesarean delivery.","From enrollment until delivery.",{"measure":23,"description":24,"timeFrame":21},"Indication for cesarean delivery","Rate of failed induction of labor, arrest of active phase, arrest of descent, non-reassuring fetal condition, maternal request, other.",{"measure":26,"description":27,"timeFrame":28},"Delivery within 12 hours of induction.","Incidence of delivery within 12 hours of induction.","Time from induction until delivery.",{"measure":30,"description":31,"timeFrame":32},"Delivery within 24 hours of Induction","Incidence of delivery within 24 hours of induction.","Time of induction to time of delivery.",{"measure":34,"description":35,"timeFrame":36},"Delivery within 36 hours of Induction","Incidence of delivery within 36 hours of induction.","From time of induction to time of delivery.",{"measure":38,"description":39,"timeFrame":36},"Delivery within 48 hours of Induction","Incidence of delivery within 48 hours of induction.",{"measure":41,"description":42,"timeFrame":43},"Perineal Lacerations (Degree I-IV)","Degree of perineal lacerations occurring during delivery (first to fourth degree).","From time of enrollment to time of delivery.",{"measure":45,"description":46,"timeFrame":47},"Postpartum hemorrhage","Blood loss \\>1000 mL","Time of enrollment to time of delivery.",{"measure":49,"description":50,"timeFrame":51},"Blood Transfusion","Incidence of blood transfusions required during or after delivery.","From time of enrollment to hospital discharge (up to 42 days post-delivery).",{"measure":53,"description":54,"timeFrame":51},"Isolated maternal fever","Incidence of maternal fever (T\\>38°C)",{"measure":56,"description":57,"timeFrame":51},"Diagnosed Endometritis","The number of endometritis based on clinical signs and diagnostic tests.",{"measure":59,"description":60,"timeFrame":51},"Wound Separation\u002FInfection","Incidence of wound separation or infection requiring additional closure or antibiotics.",{"measure":62,"description":63,"timeFrame":51},"Intraamniotic Infection","Presence of maternal fever, tachycardia, and\u002For fundal tenderness suggesting intraamniotic infection.",{"measure":65,"description":66,"timeFrame":51},"Venous Thromboembolism (VTE)","Occurrence of venous thromboembolism.",{"measure":68,"description":69,"timeFrame":51},"Hysterectomy","Occurrence of hysterectomy related to delivery complications.",{"measure":71,"description":72,"timeFrame":73},"Intensive Care Unit (ICU) Admission","Admission to ICU for maternal complications.","From time of enrollment to ICU admission (up to 42 days post-delivery).",{"measure":75,"description":76,"timeFrame":77},"Maternal Death","Occurrence of maternal death during or after delivery.","From time of enrollment until maternal death (up to 42 days post-delivery).",{"measure":79,"description":80,"timeFrame":81},"Length of hospital stay","Days between admission and discharge","From time of hospital admission to time of hospital discharge (up to 50 days post-delivery).",{"measure":83,"description":84,"timeFrame":85},"Cord Prolapse","Occurrence of cord prolapse during labor.","From time of enrollment to delivery.",{"measure":87,"description":88,"timeFrame":85},"Use of Terbutaline","The number of terbutaline use for uterine contractions.",{"measure":90,"description":91,"timeFrame":85},"Placement of Intrauterine Pressure Catheter","The number of placement of intrauterine pressure catheter during labor.",{"measure":93,"description":94,"timeFrame":85},"Epidural Use","Use of epidural anesthesia during labor for pain relief.",{"measure":96,"description":97,"timeFrame":98},"Neonatal Severe Respiratory Distress Syndrome (RDS)","Need for intubation and mechanical ventilation for ≥12 hours.","From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.",{"measure":100,"description":101,"timeFrame":102},"Neonatal 5- minute Apgar score \u003C7","Incidence of 5-minute Apgar score\\\u003C7","From time of delivery up to 1 day following delivery.",{"measure":104,"description":105,"timeFrame":106},"Arterial umbilical cord pH \u003C7","Incidence of arterial umbilical cord pH \\\u003C7","From time of enrollment up to 1 day following delivery.",{"measure":108,"description":109,"timeFrame":98},"Neonatal outcome composite","Incidence of neonatal outcome composite",{"measure":111,"description":112,"timeFrame":98},"Neonatal Sepsis (Culture-proven or Presumed)","Incidence of neonatal sepsis, culture-proven or presumed.",{"measure":114,"description":115,"timeFrame":116},"Neonatal Intensive Care Unit (NICU) Admission","Admission of neonate to NICU.","From time of delivery to NICU admission. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.",{"measure":118,"description":119,"timeFrame":98},"Hypoxic-Ischemic Encephalopathy","Diagnosis of hypoxic-ischemic encephalopathy in neonates.",{"measure":121,"description":122,"timeFrame":123},"Neonatal Intraventricular Hemorrhage (Grade 3 or 4)","Occurrence of grade 3 or 4 intraventricular hemorrhage in neonates.","From time of enrollment to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.",{"measure":125,"description":126,"timeFrame":127},"Diagnosed Neonatal Necrotizing Enterocolitis","The number of diagnosis of necrotizing enterocolitis in the neonate.","From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.",{"measure":129,"description":130,"timeFrame":127},"Neonatal Head Cooling Therapy","Use of head cooling therapy for neonates to prevent brain injury.",{"measure":132,"description":133,"timeFrame":127},"Neonatal Blood Transfusion","Need for blood transfusion in the neonate.",{"measure":135,"description":136,"timeFrame":137},"NICU Stay >48 hours","Incidence of NICU stay lasting longer than 48 hours.","From NICU admission to NICU discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.",{"measure":139,"description":140,"timeFrame":127},"Neonatal Length of Stay (days)","Total length of neonatal stay in the hospital.",{"measure":142,"description":143,"timeFrame":144},"Bishop Score: Cervical Dilation, Effacement, Station, Position, Consistency","Baseline Bishop score (0-13, with 13 being more favorable to labor) and its changes during labor to assess cervical readiness for induction.","From time of enrollment to time of induction up to 1 week.",{"allocation":146,"interventionModel":147,"interventionModelDescription":11,"primaryPurpose":148,"observationalModel":11,"timePerspective":11,"maskingInfo":149},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":150,"maskingDescription":11,"whoMasked":151},"SINGLE",[152],"OUTCOMES_ASSESSOR",[154,161],{"label":155,"type":156,"description":157,"interventionNames":158},"5% dextrose and Lactate Ringer","ACTIVE_COMPARATOR","Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.",[159,160],"Drug: 5% Dextrose (D5) in Normal Saline (NS)","Drug: Lactate Ringer",{"label":162,"type":156,"description":163,"interventionNames":164},"Lactate Ringer only","Participants randomized to this arm will receive an intravenous Lactate Ringer solution only.",[160],[166,171],{"type":167,"name":168,"description":169,"armGroupLabels":170,"otherNames":11},"DRUG","5% Dextrose (D5) in Normal Saline (NS)","A solution of 5% dextrose and lactate ringer will be given to one group of participants.",[155],{"type":167,"name":172,"description":173,"armGroupLabels":174,"otherNames":11},"Lactate Ringer","A Lactate Ringer solution will be given to one group of participants.",[155,162],[176],{"name":177,"role":178,"phone":179,"phoneExt":11,"email":180},"Tetsuya Kawakita, MD","CONTACT","757-446-7900","kawakit@odu.edu",[182,198],{"facility":183,"status":184,"city":185,"state":186,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":195,"contacts":196},"Sentara Norfolk General Hospital","RECRUITING","Norfolk","Virginia","23507","United States","US",{"type":191,"coordinates":192},"Point",[193,194],-76.28522,36.84681,{"lat":194,"lon":193},[197],{"name":177,"role":178,"phone":179,"phoneExt":11,"email":180},{"facility":199,"status":184,"city":200,"state":11,"zip":11,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":11},"Policlinico di Modena","Modena","Italy","IT",{"type":191,"coordinates":204},[205,206],10.92539,44.64783,{"lat":206,"lon":205},{"type":209,"investigatorFullName":177,"investigatorTitle":210,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Associate Professor",[212],{"name":213,"class":6},"University of Modena and Reggio Emilia","100602486",false,"NCT07124130","Lactated Ringer's and Dextrose 5% vs Only Lactated Ringer's in Labor","Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes","Inclusion Criteria:\n\n* Nulliparous women\n* Age 18 years or older and able to provide informed consent\n* Singleton pregnancy at term\n* Induction of labor\n* Cephalic presentation\n* Unfavorable cervix (Bishop score ≤ 6)\n\nExclusion Criteria:\n\n* Age under 18 years\n* Involuntarily confined or detained\n* Considered as having diminished decision-making capacity\n* Spontaneous labor (cervical exam between 5-6 cm) with or without ruptured membraned\n* Favorable cervix (Bishop score \\>6)\n* Diabetes mellitus (both gestational and pre-gestational)\n* Structural renal disease\n* Acute or chronic kidney disease resulting in abnormal creatinine or proteinuria\n* Evidence of chorioamnionitis or non-reassuring fetal testing at the time of enrollment\n* Pyrexia (\\>38.0 degrees Celsius)\n* Stillbirth\n* Planned cesarean delivery\n* Women presenting with emergent circumstances for labor induction","FEMALE","18 Years",{"count":223,"type":224},158,"ESTIMATED","INTERVENTIONAL",[227],"PHASE4","The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are:\n\n1. Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers?\n2. Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.",[230],"Induced Labor",[232,233,234,235],"Induced labor","5% dextrose","Lactated Ringers","duration of labor","2025-08-18",{"date":238,"type":239},"2025-08-22","ACTUAL",{"date":241,"type":224},"2025-09",{"date":243,"type":224},"2026-03",{"name":5,"class":6},2]