[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07685730":3,"trial-entities:NCT07685730":94,"trial-summary:NCT07685730":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":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":44,"minimum_age":45,"maximum_age":24,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":64,"locations":67,"central_contacts":87,"overall_officials":91,"references":92,"see_also_links":93},"NCT07685730","2024H0319","Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight","Comparative Analysis of the Predictive Performance of Noninvasive Beat-by-Beat Blood Pressure and Flow Measurements at the Lower Extremity Versus the Upper Extremity for Neonatal Outcomes Under Spinal Anesthesia for Elective Cesarean Delivery","RECRUITING","2029-08-06","2026-06","2026-07-06","2025-02-06","Ohio State University","OTHER",false,"This is a single-center, prospective observational study in patients undergoing cesarean delivery under spinal or combined spinal-epidural anesthesia. It compares whether continuous noninvasive hemodynamic measurements from the lower extremity (toe) better predict neonatal outcomes than upper extremity (arm\u002Ffinger) measurements during spinal-induced hypotension.\n\nParticipants receive standard spinal anesthesia and routine blood pressure management, with additional monitoring using the ClearSight™ system at both upper and lower extremities from before spinal anesthesia through delivery.\n\nThe primary outcome is a composite of neonatal outcomes (APGAR scores, need for respiratory support, cord gases, and NICU admission). Secondary outcomes include maternal side effects and comfort.\n\nOverall, the study evaluates whether lower-extremity hemodynamic monitoring improves detection of clinically relevant hypotension and prediction of neonatal outcomes compared to traditional arm measurements.","Enrolled parturients undergoing elective cesarean delivery under spinal anesthesia will participate in this prospective, observational study following informed consent. Standard perioperative care will be maintained, including administration of spinal anesthesia (1.6 mL of 0.75% hyperbaric bupivacaine with fentanyl 10 mcg and morphine 100 mcg), crystalloid co-loading, and a prophylactic phenylephrine infusion. For study purposes, the ClearSight™ system will be applied noninvasively to both the upper and lower extremities, with a finger cuff placed on the ring finger of the arm opposite the intravenous line and a toe cuff placed on the left foot, while a standard oscillometric blood pressure cuff will be placed on the same arm. Continuous beat-by-beat blood pressure and flow measurements will be recorded from 3 minutes prior to spinal anesthesia placement until 3 minutes after neonatal delivery, alongside routine intermittent arm cuff measurements. Intraoperative maternal events and hemodynamic parameters will be documented, and neonatal outcome data-including Apgar scores, need for airway support, and NICU admission-will be extracted from the electronic medical record. No additional interventions beyond standard care will be performed, and all data collected will be used to compare the predictive performance of upper versus lower extremity hemodynamic measurements for neonatal outcomes.",[19,20,21],"Anesthesia","Pregnancy Related","Blockades Neuromuscular",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},327,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","ClearSight","The ClearSight system provides continuous blood pressure and advanced hemodynamic parameters from a noninvasive finger cuff sensor. Therefore, placing both cuff sensors in different arms will ensure no interference with the ClearSight readings due to the conventional blood pressure cuff inflation.",[35],"Pregnant Women undergoing Cesarean Delivery",[37],{"measure":38,"description":39,"timeFrame":40},"Incidences of FAAAN composite poor neonatal outcomes","FAAAN is a composite neonatal outcome measure used in this study to capture clinically relevant indicators of neonatal well-being and immediate post-delivery support needs. It includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), and NICU admission. The primary outcome is the incidence of a composite of poor neonatal outcomes, referred to as FAAAN. This composite includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), NICU admission, cord blood gas abnormalities, and delayed cord clamping.","24 Hours after delivery",[42],{"measure":43,"timeFrame":40},"Maternal nausea\u002Fvomiting, arm, finger, and toe comfort, and shivering","FEMALE","18 Years",true,{"inclusion":48,"exclusion":54,"raw_text":63},[49,50,51,52,53],"Age ≥ 18 years old","Singleton pregnancy","Gestational age ≥ 37 weeks","Women undergoing CD under SAB or Combined Spinal-Epidural (CSE) electively.","Ability to consent in English and in Spanish language",[55,56,57,58,59,60,61,62],"CD under or converted to general anesthesia","CD under epidural anesthesia or converted to epidural anesthesia","Diabetes Mellitus (DM)\u002FGestational Diabetes Mellitus (GDM)","Evidence of unstable cardiac disease other than HDP (including chronic hypertension, gestational hypertension, preeclampsia-eclampsia, and chronic hypertension with superimposed preeclampsia) judged by the investigator to have any impact on BP will make the subject unsuitable for participation in the study","Documented fetal anomaly\u002F congenital malformations and genetic syndromes","Intrauterine growth retardation","Unable to consent in English\u002FSpanish.","Prisoners","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Singleton pregnancy\n* Gestational age ≥ 37 weeks\n* Women undergoing CD under SAB or Combined Spinal-Epidural (CSE) electively.\n* Ability to consent in English and in Spanish language\n\nExclusion Criteria:\n\n* CD under or converted to general anesthesia\n* CD under epidural anesthesia or converted to epidural anesthesia\n* Diabetes Mellitus (DM)\u002FGestational Diabetes Mellitus (GDM)\n* Evidence of unstable cardiac disease other than HDP (including chronic hypertension, gestational hypertension, preeclampsia-eclampsia, and chronic hypertension with superimposed preeclampsia) judged by the investigator to have any impact on BP will make the subject unsuitable for participation in the study\n* Documented fetal anomaly\u002F congenital malformations and genetic syndromes\n* Intrauterine growth retardation\n* Unable to consent in English\u002FSpanish.\n* Prisoners",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":84},"The Ohio State University","Columbus","Ohio","43210","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Alberto Uribe, MD","CONTACT","6142933559","alberto.uribe@osumc.edu",{"name":81,"role":77,"phone":82,"email":83},"Ling-Qun Hu, MD","6142936302","LingQun.Hu@osumc.edu",{"lat":85,"lon":86},39.96118,-82.99879,[88,89],{"name":81,"role":77,"phone":82,"email":83},{"name":76,"role":77,"phone":78,"email":90},"Alberto.uribe@osumc.edu",[],[],[],{"nct_id":4,"conditions":95,"biomarkers":98},[96,97],"Cesarean Section","Pregnancy",[],{"nct_id":4,"found":46,"summary":100,"prompt_version":110},{"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 record information without giving new treatments. It plans to include 327 participants.","completed","ClearSight Monitoring During Cesarean Delivery","This observational study is looking at whether continuous blood pressure measurements from your toe (lower extremity) are better at predicting how your baby will do after a cesarean delivery than measurements from your arm or finger (upper extremity). This is for women having a cesarean delivery with spinal anesthesia. You will receive standard spinal anesthesia and routine blood pressure care. The ClearSight™ system, which measures blood pressure non-invasively, will be used on both your upper and lower body. The main goal is to see if these measurements can predict a combination of poor neonatal (newborn) outcomes, like Apgar scores and need for breathing support, within 24 hours after delivery. This study is currently unclear on its recruitment status and plans to enroll 327 participants.","Neonatal outcomes will be measured at 24 hours after delivery.",124,"You will have the ClearSight™ system applied to both your upper and lower extremities from 3 minutes before spinal anesthesia until 3 minutes after your baby is delivered. Routine blood pressure measurements will also be taken.","Not stated in the trial record.",[32],"v2"]