[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468639":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":68,"collaborators":71,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":25,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Women and Infants Hospital of Rhode Island","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Jada® System","EXPERIMENTAL","Patients in this group will have the Jada® System applied when the initial medical treatment fails, and estimated blood loss reaches 1000 mL. It is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted.",[13],"Device: Jada® System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","ACTIVE_COMPARATOR","Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy",[19],"Other: Standard care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","This is a U.S. FDA-cleared device intended for treatment of PPH when conservative management is warranted. The device is made of medical grade silicone. The distal end, which is placed in the uterus, is an elliptical loop. The circular cervical seal, just outside the external cervical os, is filled with 60 - 120 mL sterile water. Low-level vacuum (80 ± 10 mm Hg) is applied and pooled blood is evacuated from the uterus as it collapses. Once there is no bleeding, the device remains in the uterus for at least 1 hour. The suction is then disconnected, the seal emptied of water, the device left in place, and the patient monitored for an additional 30 minutes. If bleeding remains controlled, the device is removed. If bleeding is uncontrolled with the Jada® System patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients in this group will receive care according to the treatment algorithm for PPH from uterine atony at the two teaching hospitals in Ghana. Possible interventions include additional uterotonics, tranexamic acid, and condom catheter balloon uterine tamponade. If bleeding is uncontrolled, patients will have surgical intervention with options of uterine vascular ligation, uterine compression sutures or hysterectomy.",[15],[30],{"name":31,"affiliation":5,"role":32},"Methodius Tuuli, MD, MPH, MBA","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Crystal Ware, BSN, CCRP","CONTACT","401-274-1122","cware@wihri.org",[40,56],{"facility":41,"status":42,"city":43,"state":44,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Komfo Anokye Teaching Hospital","RECRUITING","Kumasi","Ashanti Region","Ghana","GH",{"type":48,"coordinates":49},"Point",[50,51],-1.62443,6.68848,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":25,"phoneExt":25,"email":25},"Edward Dassah, MBChB, PhD",{"facility":57,"status":42,"city":58,"state":59,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Korle-bu Teaching Hospital","Accra","Greater Accra Region",{"type":48,"coordinates":61},[62,63],-0.1969,5.55602,{"lat":63,"lon":62},[66],{"name":67,"role":36,"phone":25,"phoneExt":25,"email":25},"Samuel Oppong, MBChB",{"type":32,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Methodius Tuuli","Professor and Chair of Obstetrics and Gynecology",[72,74,76],{"name":73,"class":6},"Washington University School of Medicine",{"name":75,"class":6},"University of Ghana",{"name":77,"class":6},"Kwame Nkrumah University of Science and Technology","100468639","novel-vacuum-induced-hemorrhage-control-for-postpartum-hemorrhage-100468639",false,"NCT05382403","Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage","Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial","NOVIC","Inclusion Criteria:\n\n* 18 years or older\n* Delivery at 34 weeks or greater\n* Cumulative blood loss \\>1000ml within 24 hours after delivery\n* Uterine atony\n* Receipt of first-line uterotonics\n* Cervix at least 3cm dilated at cesarean section\n\nExclusion Criteria:\n\n* Patient unwilling or unable to provide informed consent\n* Retained placenta or other known cause of postpartum hemorrhage\n* Placenta accreta spectrum\n* Coagulopathy\n* Rupture uterus\n* Surgical management immediately needed for life-threatening bleeding\n* Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection","FEMALE","18 Years","44 Years",{"count":90,"type":91},424,"ESTIMATED","INTERVENTIONAL",[94],"NA","This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.",[97,98],"Postpartum Hemorrhage","Maternal Death","2023-12-14",{"date":101,"type":102},"2023-12-21","ACTUAL",{"date":104,"type":102},"2023-10-23",{"date":106,"type":91},"2027-04-30",{"name":5,"class":6},2]