[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06199154":3,"trial-entities:NCT06199154":165,"trial-summary:NCT06199154":168},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":44,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":110,"locations":113,"central_contacts":132,"overall_officials":137,"references":138,"see_also_links":164},"NCT06199154","HP-00108436","Induction of Labor in Morbidly Obese Patients","Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial","RECRUITING","2027-05","2026-07","2026-07-29","2024-07-15","University of Maryland, Baltimore","OTHER",true,"The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \\>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.","The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI \\>40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity.\n\nThe investigators plan to conduct a randomized controlled double blinded trial. Patients who are scheduled for induction of labor after 34 weeks gestation, have a BMI \\>40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.",[19,20],"Morbid Obesity","Pregnancy",[22,23,24],"induction of labor","morbid obesity","misoprostol","INTERVENTIONAL","TREATMENT",[28],"EARLY_PHASE1",{"count":30,"type":31},162,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Misoprostol","Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.",[38,39],"Control - 25 mcg vaginal misoprostol","Intervention - 50 mcg vaginal misoprostol",[41],{"measure":42,"timeFrame":43},"Achievement of complete cervical dilation","Start of IOL until complete dilation",[45,47,50,52,55,57,59,61,64,66,68,70,72,74,77,80],{"measure":46,"timeFrame":43},"Time interval from start of induction of labor (IOL) to complete cervical dilation",{"measure":48,"timeFrame":49},"Achievement of 6 cm cervical dilation\u002Factive labor","Start of IOL until 6 cm dilation",{"measure":51,"timeFrame":49},"Time interval from start of IOL to 6 cm cervical dilation\u002Factive labor",{"measure":53,"timeFrame":54},"Time interval from start of IOL to vaginal delivery","Start of IOL until delivery",{"measure":56,"timeFrame":54},"Time interval from start of IOL to delivery",{"measure":58,"timeFrame":54},"Incidence of vaginal deliveries",{"measure":60,"timeFrame":54},"Incidence of cesarean deliveries",{"measure":62,"description":63,"timeFrame":54},"Indication for cesarean delivery","Maternal or Fetal",{"measure":65,"timeFrame":54},"Cervical exam at time of cesarean delivery",{"measure":67,"timeFrame":54},"Number of patients with tachysystole",{"measure":69,"timeFrame":54},"Number of patients with tachysystole with non reassuring fetal heart rate (NRFHT)",{"measure":71,"timeFrame":54},"Number of patients requiring terbutaline",{"measure":73,"timeFrame":54},"Number of patients with chorioamnionitis",{"measure":75,"timeFrame":76},"Number of patients with postpartum hemorrhage","Start of IOL until discharge, assessed up to 4 days",{"measure":78,"timeFrame":79},"Composite maternal morbidity (need for transfusion, sepsis, ICU admission, death)","Start of IOL until postpartum day 4",{"measure":81,"timeFrame":82},"Composite neonatal morbidity (NICU admission, Apgar score =\u003C7 at 5 minutes, sepsis, cord gas arterial pH \u003C7.10 and\u002For base deficit \u003C -12, active cooling protocol, death)","Start of IOL until discharge or day of life 30","FEMALE","18 Years",null,false,{"inclusion":88,"exclusion":96,"raw_text":109},[89,90,91,92,93,94,95],"Morbidly obese (BMI ≥ 40 kg\u002Fm2) at admission for induction of labor","Speaks English or Spanish","Gestational age between 34 weeks and 0 days and 42 weeks and 6 days","Age 18 years old or older","Viable, single, cephalic fetus","Intent to proceed with cervical ripening - cervical exam: dilation \\\u003C 5 cm","Contractions \\\u003C 5 per 10 minutes",[97,98,99,100,101,102,103,104,105,106,107,108],"History of cesarean delivery","Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)","Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)","Contraindications to labor (cardiac, neurosurgical, need for cesarean)","Age \\\u003C 18yo","Fetal growth restriction with abnormal umbilical artery Doppler indices","Cervical dilation \\>5 cm","Contractions \\>5 per 10 minutes","Significant vaginal bleeding with concern for placental abruption","Non-reassuring fetal status or fetal heart rate decelerations","Fetal demise or major fetal anomaly","Inability to give consent","Inclusion Criteria:\n\n* Morbidly obese (BMI ≥ 40 kg\u002Fm2) at admission for induction of labor\n* Speaks English or Spanish\n* Gestational age between 34 weeks and 0 days and 42 weeks and 6 days\n* Age 18 years old or older\n* Viable, single, cephalic fetus\n* Intent to proceed with cervical ripening - cervical exam: dilation \\\u003C 5 cm\n* Contractions \\\u003C 5 per 10 minutes\n\nExclusion Criteria:\n\n* History of cesarean delivery\n* Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)\n* Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)\n* Contraindications to labor (cardiac, neurosurgical, need for cesarean)\n* Age \\\u003C 18yo\n* Fetal growth restriction with abnormal umbilical artery Doppler indices\n* Cervical dilation \\>5 cm\n* Contractions \\>5 per 10 minutes\n* Significant vaginal bleeding with concern for placental abruption\n* Non-reassuring fetal status or fetal heart rate decelerations\n* Fetal demise or major fetal anomaly\n* Inability to give consent",[111,112],"ADULT","OLDER_ADULT",[114],{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":129},"University of Maryland Medical Center","Baltimore","Maryland","21201","United States",[121,126],{"name":122,"role":123,"phone":124,"email":125},"Rosa Drummond, MD","CONTACT","410-328-6436","rosa.drummond@umm.edu",{"name":127,"role":128},"Krista Mehlhaff, DO","PRINCIPAL_INVESTIGATOR",{"lat":130,"lon":131},39.29038,-76.61219,[133,135],{"name":122,"role":123,"phone":134,"email":125},"4103285965",{"name":127,"role":123,"phone":134,"email":136},"KMehlhaff@som.umaryland.edu",[],[139,142,144,146,149,152,155,158,161],{"type":140,"citation":141},"BACKGROUND","Hoyert, Donna L. \"Maternal Mortality Rates in the United States, 2021.\" Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 16 Mar. 2023, www.cdc.gov\u002Fnchs\u002Fdata\u002Fhestat\u002Fmaternal-mortality\u002F2021\u002Fmaternal-mortality-rates-2021.htm.",{"type":140,"citation":143},"MarchofDimes. \"Total Cesarean Deliveries by Maternal Race\u002FEthnicity: United States, 2019-2021 Average.\" March of Dimes | PeriStats, www.marchofdimes.org\u002Fperistats\u002Fdata?reg=99&top=8&stop=356&lev=1&slev=1&obj=1. Accessed 14 Nov. 2023.",{"type":140,"citation":145},"\"Adult Obesity Facts.\" Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 17 May 2022, www.cdc.gov\u002Fobesity\u002Fdata\u002Fadult.html.",{"pmid":147,"type":140,"citation":148},"30648804","Ellis JA, Brown CM, Barger B, Carlson NS. Influence of Maternal Obesity on Labor Induction: A Systematic Review and Meta-Analysis. J Midwifery Womens Health. 2019 Jan;64(1):55-67. doi: 10.1111\u002Fjmwh.12935. Epub 2019 Jan 16.",{"pmid":150,"type":140,"citation":151},"30089070","Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056\u002FNEJMoa1800566.",{"pmid":153,"type":140,"citation":154},"27560557","Beckwith L, Magner K, Kritzer S, Warshak CR. Prostaglandin versus mechanical dilation and the effect of maternal obesity on failure to achieve active labor: a cohort study. J Matern Fetal Neonatal Med. 2017 Jul;30(13):1621-1626. doi: 10.1080\u002F14767058.2016.1220523. Epub 2016 Aug 25.",{"pmid":156,"type":140,"citation":157},"24116732","O'Dwyer V, O'Kelly S, Monaghan B, Rowan A, Farah N, Turner MJ. Maternal obesity and induction of labor. Acta Obstet Gynecol Scand. 2013 Dec;92(12):1414-8. doi: 10.1111\u002Faogs.12263.",{"pmid":159,"type":140,"citation":160},"19935035","Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009 Dec;114(6):1315-1321. doi: 10.1097\u002FAOG.0b013e3181bfb39f.",{"pmid":162,"type":140,"citation":163},"36311296","Drummond R, Patel M, Myers M, Ritter A, Hurvitz JA, Goetzinger KR, Crimmins SD. Class III obesity is an independent risk factor for unsuccessful induction of labor. AJOG Glob Rep. 2022 Sep 23;2(4):100109. doi: 10.1016\u002Fj.xagr.2022.100109. eCollection 2022 Nov.",[],{"nct_id":4,"conditions":166,"biomarkers":167},[19,20],[],{"nct_id":4,"found":15,"summary":169,"prompt_version":178},{"design":170,"status":171,"heading":6,"summary":172,"follow_up":173,"word_count":174,"commitments":175,"compensation":176,"drugs_mentioned":177},"This is a randomized, controlled, double-blind study comparing two different doses of Misoprostol. It plans to enroll 162 participants.","completed","This study is looking at different doses of a medication called Misoprostol to help start labor (induction of labor) in pregnant people who have morbid obesity (a Body Mass Index or BMI of 40 or higher). The goal is to see if one dose of Misoprostol (25 mcg or 50 mcg, given vaginally every 4 hours) works better to help achieve a vaginal delivery. This is important because morbid obesity can make it harder to have a vaginal delivery, sometimes leading to a C-section. Researchers hope to find a way to improve vaginal delivery rates and reduce surgical risks for these patients. The study plans to enroll 162 participants and is currently recruiting. You may be able to join if you are 18 or older, speak English or Spanish, are between 34 and 42 weeks pregnant with a single baby, and have a BMI of 40 or higher.","Not specified.",148,"Participants will receive either 25 mcg or 50 mcg of vaginal Misoprostol every 4 hours. The study measures the time from the start of labor induction until complete cervical dilation.","Not stated in the trial record.",[35],"v2"]