[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580896":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":28,"collaborators":32,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":20,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":20,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":20},{"fullName":5,"class":6},"Fundacion Clinica Valle del Lili","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Pregnant women with stage II postpartum hemorrhage, after vaginal delivery, who have had the JADA device implemented and meet INVIMA's definition of use of the instrument: the JADA system is intended to provide control and treatment of abnormal postpartum uterine bleeding or postpartum hemorrhage when conservative management is warranted, attended in hospitals in the context of the Godfather Hospital Strategy in the department of Valle del Cauca.",[13],"Device: Vacuum- Induce Hemorrhage Control",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Vacuum- Induce Hemorrhage Control","The JADA System is designed for single use only and is composed of medical grade silicone. Its components include an intrauterine loop with protected vacuum pores, a cervical seal with a sealing valve for infusing saline and a vacuum connector port for applying suction. The intrauterine loop is located at the distal end of a tube and contains 20 protected vacuum pores oriented inward along the loop. This shielded design facilitates intracavitary suction by shielding maternal tissue from the vacuum source and prevents clogging of the vacuum pores with tissue or clot.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Maria F Escobar, Gynecologist and Obstetrician","CONTACT","+57 315 433 1584","3055","maria.escobar.vi@fvl.org.co",{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","María Fernanda Escobar","Global health equity unit director",[33],{"name":34,"class":35},"Hospital Universitario del Valle Evaristo Garcia","UNKNOWN","100580896","outcomes-and-perceptions-of-the-implementation-of-the-jada-device-in-a-stage-ii-postpartum-hemorrhage-management-protocol-in-referral-hospitals-of-the-colombian-pacific-region-100580896",false,"NCT06843265","Outcomes and Perceptions of the Implementation of the JADA Device in a Stage II Postpartum Hemorrhage Management Protocol in Referral Hospitals of the Colombian Pacific Region","Outcomes and Perceptions of the Implementation of the JADA Device in a Stage II Postpartum Hemorrhage Management Protocol in Referral Hospitals of the Colombian Pacific Region: a Cohort Study","JADAValle","Inclusion Criteria:\n\n* Pregnant women who are admitted to the obstetrics service scheduled for vaginal delivery in any of the participating hospitals: Fundación Valle del Lili, Hospital Universitario del Valle and Hospital Luis Ablanque de la Plata.\n* Patient admitted during the shift of one of the gynecologists trained in the use of the JADA device in the context of the research project.\n\nCriteria for the use of JADA device:\n\n* Pregnant women over or equal to 18 years of age.\n* Gestational age of pregnancy greater than 32 weeks of gestation.\n* Pregnant with vaginal delivery.\n* Pregnant with postpartum hemorrhage due to uterine atony that does not respond to treatment with uterotonics and uterine massage.\n* Postpartum hemorrhage uterine stage\u002Fstage II.\n* Vaginal delivery attended in a health institution in the context of the Hospital Padrino strategy (Fundación Valle del Lili or Hospital Universitario del Valle or Hospital Luis Ablanque de la Plata).\n\nExclusion Criteria:\n\n* Patients who, according to the attending physician's criteria, are not candidates for vaginal delivery.\n* Abnormality of the normal uterine anatomy.\n* Placental abnormalities.\n* Maternal anemia with hemoglobin less than 7 mg\u002Fdl prior to delivery.\n* Those who do not sign informed consent.","FEMALE","18 Years",{"count":47,"type":48},24,"ESTIMATED","INTERVENTIONAL",[51],"NA","This study focuses on postpartum hemorrhage (PPH), a condition that stands out as the leading cause of global maternal mortality. Annually, about 14 million women experience PPH, resulting in approximately 70,000 deaths. This condition presents a higher risk in low- and middle-income countries (LMICs), particularly where access to quality care is limited. Recognizing the urgency of addressing this public health problem, the Colombian Ministry of Health and Social Protection has implemented the Maternal Mortality Reduction Acceleration Plan (PARE) to improve maternal mortality indicators and meet the Sustainable Development Goals (SDGs).\n\nThe project will evaluate the results and perception of a new device in the management of stage II PPH in referral hospitals in the department of Valle del Cauca, integrated in the Hospital Padrino strategy. This initiative seeks not only to improve the understanding and treatment of PPH, but also to strengthen institutional capacities through education, creation of telecare networks and care services adapted to local needs.",[54],"Post Partum Haemorrhage",[56,57,58],"maternal mortality","Shock Index","care bundle","NOT_YET_RECRUITING","2025-02-20",{"date":62,"type":63},"2025-02-24","ACTUAL",{"date":65,"type":48},"2025-06-01",{"date":67,"type":48},"2025-12-31",{"name":5,"class":6}]