[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04229043":3,"trial-entities:NCT04229043":97,"trial-summary:NCT04229043":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":68,"locations":70,"central_contacts":93,"overall_officials":94,"references":95,"see_also_links":96},"NCT04229043","2019P001110","Gastric Emptying of Water and Sports Drink in Labor","Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor","RECRUITING","2027-12-31","2025-10","2025-10-23","2021-02-01","Beth Israel Deaconess Medical Center","OTHER",false,"To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.","This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.\n\nCohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group.\n\nStudy Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4\u002F10, or two hours after the sports drink.\n\nHypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.",[19,20],"Pregnancy","Gastric Emptying",[],"INTERVENTIONAL",[24],"NA",{"count":26,"type":27},108,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIETARY_SUPPLEMENT","Sports drink","Drink that will be ingested",[34,35],"Early labor, analgesia: Sports drink","Early labor, no analgesia: Sports drink",{"type":30,"name":37,"description":32,"armGroupLabels":38},"Water",[39,40],"Early Labor, no analgesia: Water","Early labor, analgesia: Water",[42],{"measure":43,"description":44,"timeFrame":45},"Gastric emptying half time","The time in minutes that half of the volume of the stomach has emptied","60 minutes",[47],{"measure":48,"description":49,"timeFrame":45},"Hunger","The amount of hunger that the subject feels measured on a visual analogue 10-centimeter line, with the left (0 cm) being labeled 'No Hunger' and the right (10 cm) being labeled 'Maximum hunger'","FEMALE","18 Years","50 Years",{"inclusion":54,"exclusion":59,"raw_text":67},[55,56,57,58],"Gestational age of 36 weeks or greater","American Society of Anesthesiology Physical Status 2 or 3","Induction of labor or early labor (cervical dilation \\\u003C 6cm)","Singleton gestation",[60,61,62,63,64,65,66],"Recent food ingestion (\\\u003C3 hours)","Preeclampsia","Receiving magnesium sulfate","Having received narcotics within 12 hours","Diabetes mellitus","Multiple gestations","Active nausea or reflux symptoms","Inclusion Criteria:\n\n* Gestational age of 36 weeks or greater\n* American Society of Anesthesiology Physical Status 2 or 3\n* Induction of labor or early labor (cervical dilation \\\u003C 6cm)\n* Singleton gestation\n\nExclusion Criteria:\n\n* Recent food ingestion (\\\u003C3 hours)\n* Preeclampsia\n* Receiving magnesium sulfate\n* Having received narcotics within 12 hours\n* Diabetes mellitus\n* Multiple gestations\n* Active nausea or reflux symptoms",[69],"ADULT",[71],{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":90},"Beth Isreal Deaconess Medical Center","Boston","Massachusetts","02215","United States",[78,83,86,88],{"name":79,"role":80,"phone":81,"email":82},"Diana Cepeda","CONTACT","6176674113","dcepeda@bidmc.harvard.edu",{"name":84,"role":85},"Yunping Li, MD","SUB_INVESTIGATOR",{"name":87,"role":85},"Kowalczyk John, MD",{"name":89,"role":85},"Sween Lindsay, MD",{"lat":91,"lon":92},42.35843,-71.05977,[],[],[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[19],[],{"nct_id":4,"found":101,"summary":102,"prompt_version":111},true,{"design":103,"status":104,"heading":6,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is a randomized, un-blinded study comparing water and a sports drink in two groups of women in early labor: those with and without epidural pain relief. It plans to enroll 108 participants.","completed","This study is looking at how quickly your stomach empties when you're in early labor and drink either water or a sports drink. Researchers want to see if water empties faster than a sports drink. They also want to compare how quickly your stomach empties if you have an epidural (pain relief) versus if you don't. You could join if you are a woman between 18 and 50 years old, at least 36 weeks pregnant, and in early labor (cervix less than 6cm dilated). You cannot have eaten recently (within 3 hours), have preeclampsia, diabetes, or have received certain medications. The main goal is to measure the \"gastric emptying half time\" (how long it takes for half of the drink to leave your stomach) at 60 minutes. The study is currently unclear on its recruitment status and plans to enroll 108 participants.","The study finishes once you consume food or drink, feel hunger ≥4\u002F10, or two hours after drinking the sports drink.",142,"You will drink either water or a sports drink, and the volume in your stomach will be measured using ultrasound over 60 minutes. You will also be asked about your hunger levels for two hours.","Not stated in the trial record.",[31,37],"v2"]