[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02193542":3,"trial-entities:NCT02193542":95,"trial-summary:NCT02193542":99},{"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":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":34,"sex":35,"minimum_age":24,"maximum_age":24,"healthy_volunteers":36,"eligibility_criteria":37,"std_ages":43,"locations":47,"central_contacts":73,"overall_officials":74,"references":77,"see_also_links":94},"NCT02193542","bwhobanes-DADB","Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients","Prospective Observation Study of Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients","RECRUITING","2027-06-30","2026-07","2026-07-13","2014-07-01","Brigham and Women's Hospital","OTHER",false,"Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: \"Regional anesthesia\" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or \"General anesthesia\", where the mother is given intravenous medication and is kept asleep.\n\nRegional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.\n\nIf general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.\n\nThe purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.",[18],"Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered",[20,21,22],"regional anesthesia","general anesthesia","obstetric","OBSERVATIONAL",null,[],{"count":27,"type":28},400,"ESTIMATED",[],[31],{"measure":32,"timeFrame":33},"incidence of difficult regional and general anesthesia","within 30 days",[],"FEMALE",true,{"inclusion":38,"exclusion":40,"raw_text":42},[39],"Pregnant woman presenting for vaginal or cesarean delivery",[41],"Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or emergent delivery","Inclusion Criteria:\n\n* Pregnant woman presenting for vaginal or cesarean delivery\n\nExclusion Criteria:\n\n* Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or emergent delivery",[44,45,46],"CHILD","ADULT","OLDER_ADULT",[48],{"facility":13,"status":8,"city":49,"state":50,"zip":51,"country":52,"contacts":53,"geoPoint":70},"Boston","Massachusetts","02215","United States",[54,59,62,64,66,68],{"name":55,"role":56,"phone":57,"email":58},"Anthony Chau, MD","CONTACT","617-732-5500","achau2@partners.org",{"name":60,"role":61},"Lawrence Tsen, MD","PRINCIPAL_INVESTIGATOR",{"name":55,"role":63},"SUB_INVESTIGATOR",{"name":65,"role":63},"Carolina Bibbo, MD",{"name":67,"role":63},"Julian Robinson, MD",{"name":69,"role":63},"Eric Cappiello, MD",{"lat":71,"lon":72},42.35843,-71.05977,[],[75],{"name":76,"affiliation":13,"role":61},"Lawrence C Tsen, MD",[78,82,85,88,91],{"pmid":79,"type":80,"citation":81},"16129992","BACKGROUND","Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097\u002F00000542-200509000-00030. No abstract available.",{"pmid":83,"type":80,"citation":84},"12972749","Hawkins JL. Anesthesia-related maternal mortality. Clin Obstet Gynecol. 2003 Sep;46(3):679-87. doi: 10.1097\u002F00003081-200309000-00020. No abstract available.",{"pmid":86,"type":80,"citation":87},"12698840","Ross BK. ASA closed claims in obstetrics: lessons learned. Anesthesiol Clin North Am. 2003 Mar;21(1):183-97. doi: 10.1016\u002Fs0889-8537(02)00051-2.",{"pmid":89,"type":80,"citation":90},"19762752","Ellinas EH, Eastwood DC, Patel SN, Maitra-D'Cruze AM, Ebert TJ. The effect of obesity on neuraxial technique difficulty in pregnant patients: a prospective, observational study. Anesth Analg. 2009 Oct;109(4):1225-31. doi: 10.1213\u002FANE.0b013e3181b5a1d2.",{"pmid":92,"type":80,"citation":93},"19420004","Fettes PD, Jansson JR, Wildsmith JA. Failed spinal anaesthesia: mechanisms, management, and prevention. Br J Anaesth. 2009 Jun;102(6):739-48. doi: 10.1093\u002Fbja\u002Faep096. Epub 2009 May 6.",[],{"nct_id":4,"conditions":96,"biomarkers":98},[97],"Pregnancy",[],{"nct_id":4,"found":36,"summary":100,"prompt_version":24},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study, meaning researchers will watch and collect information without providing any specific interventions. It plans to include about 400 pregnant women.","completed","Study on Difficult Airway and Neuraxial Placement in Obstetric Patients","This study is looking at how often pregnant women experience difficulties with two common types of anesthesia during labor or C-sections: regional anesthesia (like an epidural, where medication is given in your back while you're awake) and general anesthesia (where you're given medication intravenously to go to sleep). Doctors want to understand how frequently it's challenging to perform these procedures. This information helps anesthesiologists plan the safest care for mothers. You can join if you are a pregnant woman coming in for a vaginal or C-section delivery, but not if your delivery is urgent or emergent. The study will measure how often these difficulties occur within 30 days.","The primary endpoint, which is the incidence of difficult regional and general anesthesia, will be measured within 30 days.",108,"Not specified in the trial record.","Not stated in the trial record.",[]]