[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postpartum-hemorrhage-primary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postpartum-hemorrhage-primary":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,83,113,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100594452","u-cavit-versus-standard-of-care-for-prevention-of-atonic-postpartum-hemorrhage-after-cesarean-section-in-high-risk-women-100594452",false,"NCT07019623","U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.","Uro-catheter Vacuum-induced Uterine Tamponade (U-CaVIT) Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women: a Monocentric Randomized-controlled Pilot Study.","UCaVIT Pilot","Inclusion Criteria:\n\n* Signed informed consent\n* Maternal age ≥18 years\n* Gestational age ≥30+0 weeks of pregnancy at day of delivery\n* Vital pregnancy\n* Delivery mode: planned cesarean delivery\n* High-risk patient for PPH specified by the presence of at least one of the following characteristics: Previous PPH, obesity (BMI ≥30 kg\u002Fm2), high parity (patient who has had ≥4 previous births (live or stillborn) at ≥20 weeks of gestation), very advanced maternal age ≥45 years, multiple gestation, polyhydramnios (defined as amniotic fluid index \\> 25 cm or deepest amniotic fluid pocket \\> 8 cm) at admission to delivery, suspected fetal macrosomia (estimated fetal weight ≥ 4500g)\n\nExclusion Criteria:\n\n* Insufficient language skills in German or English to understand and sign informed consent\n* Participation in another interventional study\n* Emergency cesarean section (incl. patients undergoing cesarean after failed vaginal delivery)\n* Subjects who change their delivery plan from vaginal to cesarean section in the course of hospitalization\n* Women with regular and painful contractions and women who do not have time for sufficient consideration\n* Clinical situations in which vacuum-induced uterine tamponade is unlikely to be effective or is contraindicated:\n\n  * Uterine or vaginal anomalies (genital tract congenital anomalies)\n  * Cesarean section due to placenta previa or suspected placenta accreta spectrum\n  * Suspected uterine rupture\n  * Injuries of the cervix or vagina\n  * Submucous or intramural uterine fibroids which are buldging into the uterine cavity\n  * Deep endometriosis \\[16, 17\\]\n* Planned atony-prophylaxis with oxytocin due to contraindication for carbetocin\n* Previous MMC-repair (myelomeningocele-repair)\n* Clinical diagnosis of chorioamnionitis, sepsis\n* Known allergy to silicone\n* Known and proven diagnosis of bleeding disorder or thrombophilia\n* Known thrombocytopenia during second half of pregnancy with thrombocytes \\\u003C 100 G\u002FL\n* Known anemia during second half of pregnancy with Hb\\\u003C80","FEMALE","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery.\n\nThe U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.",[27,28,29,30,31,32,33],"Postpartum Hemorrhage (Primary)","Hemorrhage","Postpartum Complication","Delivery ,Complications,Maternal","Pregnancy Complications","Cesarean Delivery","Balloon",[35,36,37,38,39,40,41,42],"Postpartum Hemorrhage","Delivery complications","high risk patients","Pregnancy","Balloon Catheter","Tamponade","prophylactic","Vacuum-induced tamponade","RECRUITING","2026-04-17",{"date":46,"type":47},"2026-04-22","ACTUAL",{"date":49,"type":47},"2025-05-28",{"date":51,"type":21},"2026-11",{"name":53,"class":54},"Christian Haslinger","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":55},"100607360","effect-of-co-administration-of-carbetocin-and-calcium-chloride-on-uterine-tone-in-patients-undergoing-elective-cesarean-delivery-100607360","NCT07187544","Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery","Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery: a Double-blind Randomized Control Trial","Inclusion Criteria:\n\n1. Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony\n2. Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic\n\nExclusion Criteria:\n\n1. Risk factors for uterine atony including:\n\n   1. Overdistended uterus due to fetal macrosomia reported on prenatal ultrasound \\>90th centile or \\> 4000 gm, multiple gestation, grand multiparity (≥5 births at ≥ 20 weeks gestation), polyhydramnios\n   2. History of uterine atony\u002FPPH (documented with blood loss \\> 2000 ml, blood transfusion, use of surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)\n   3. Obesity with body mass index (BMI) \\> 40 kg\u002Fm2\n   4. Placenta previa and\u002For placenta accreta\n2. Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity)\n3. Patients needing intraoperative IV ceftriaxone or tetracycline.\n4. Kidney disease including Stage 3 chronic kidney disease, serum creatinine above 120 mmol\u002FL or GFR \\\u003C60 ml\u002Fmin (to prevent hypercalcemia due to reduced creatinine clearance in those with impaired kidney function as calcium is renally excreted)\n5. Calcium channel blockade within 24 hours (opposing effect)\n6. Known history of cardiac disease including arrhythmias, ischemia, and congenital heart disease (to avoid attributing cardiac symptoms to study drugs)\n7. Preexisting hypertension, preeclampsia or persistent elevated blood pressure above 160\u002F100 mmHg requiring treatment\n8. Emergency cesarean deliveries or women in labor\n9. Planned general anesthetic for patients where neuraxial is contraindicated.",true,"45 Years",{"count":66,"type":21},120,[24],"Postpartum hemorrhage (PPH) is a leading cause of maternal mortality, and its severity has been increasing globally, including in high-income countries. The most common cause of PPH is uterine atony occurring in about 70% of cases. Uterotonic agents, like oxytocin, are key in managing the third stage of labour to prevent PPH. Oxytocin is a short-acting medication and requires frequent dosing, however, carbetocin, a longer-acting analogue that can be administered as a single dose, provides sustained uterotonic activity. Calcium chloride is a readily available, inexpensive medication that has been studied as an adjunct to primary uterotonics due to its role in uterine contractility. A randomized trial found no overall reduction in blood loss with calcium chloride and oxytocin, but a subgroup analysis suggested it may reduce bleeding in cases of uterine atony. This study was conducted in the US where carbetocin is not readily available. The investigators propose a double-blind randomized trial investigating if co-administering calcium chloride with carbetocin during scheduled cesarean deliveries reduces PPH secondary to uterine atony.",[27],[71,72,73],"calcium","carbetocin","cesarean","2026-03-31",{"date":76,"type":47},"2026-04-01",{"date":78,"type":47},"2025-12-01",{"date":80,"type":21},"2026-12",{"name":82,"class":54},"Samuel Lunenfeld Research Institute, Mount Sinai Hospital",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100565782","phase-3-eve-trial--alma-systam-100565782","NCT06646653","EVE TRIAL , ALMA SYSTAM","Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Alma System in Treating Abnormal Postpartum utErine Bleeding or Hemorrhage","EVE","1. Adult Female, 18 years of age or older at time of consent.\n2. Able to understand and provide informed consent to participate in the study.\n3. Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.\n4. EBL, determined when investigator is ready to have the Alma peel pack opened:\n\n   Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL\n5. Failed first-line intervention of uterotonics and uterine massage\u002Fbimanual uterine massage to stop bleeding.\n\nNote: Uterotonic administration may continue concomitantly with and post Alma use, as long as such use does not exceed the maximum dose of the drug 10.3.2 Exclusion Criteria\n\n1. EBL \\>1500ml, to be determined when investigator is ready to have the Alma peel pack opened.\n2. Delivery at a gestational age \\\u003C 34 weeks.\n3. For Cesarean-sections birth: Cervix \\\u003C 3 cm dilated before use of Alma.\n4. PPH that the investigator determines to require more aggressive treatment, including any of the following:\n\n   1. hysterectomy;\n   2. b-lynch suture;\n   3. uterine artery embolization or ligation;\n   4. hypogastric ligation.\n5. Known uterine anomaly.\n6. Ongoing intrauterine pregnancy.\n7. Placenta abnormality including any of the following:\n\n   1. known placenta accreta;\n   2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa);\n   3. retained placenta without easy manual removal.\n8. Known uterine rupture.\n9. Unresolved uterine inversion.\n10. Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma.\n11. Current cervical cancer.\n12. Current purulent infection of vagina, cervix, uterus.\n13. Diagnosis of coagulopathy.",{"count":92,"type":21},50,[94],"PHASE3","abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening complication that requires immediate medical treatment.\n\nWhat you need to know:\n\n* Signing this form does not mean you will have an emergency postpartum bleeding.\n* We will only include you in the study IF abnormal bleeding happens after your birth.\n* If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol.\n* The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding.\n\nTreatment Schedule - Recruitment \\& Consenting\n\n* Screening and enrolment.\n* Treatment of PPH with Alma system.\n* Alma Survey\n* Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital).\n* 6-week postpartum follow-up examination.",[97,98,27],"Postpartum Haemorrhage (PPH)","PPH",[100,101,102],"Alma System","postpartum hemorrhage","pph","2026-03-25",{"date":105,"type":47},"2026-03-30",{"date":107,"type":47},"2026-01-11",{"date":109,"type":21},"2027-04",{"name":111,"class":54},"ResQ Medical Ltd",2,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":63,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":55},"100608303","obs-qor-10-in-patients-with-and-without-postpartum-hemorrhage-100608303","NCT07199803","OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage","Comparing the Obstetric Quality of Recovery-10 (OBS-QoR-10) in Patients With and Without Postpartum Hemorrhage: A Matched Case-control Study","Inclusion Criteria:\n\n* Patients aged 18 years or older who have delivered at Mount Sinai Hospital.\n* Delivery via vaginal or cesarean delivery with neuraxial analgesia or anesthesia\n* Ability to communicate in English (to answer OBSQoR-10 survey) PPH Cohort\n\n  * Quantitative Blood Loss (QBL) ≥ 1000 mL or,\n  * Transfusion of blood due to PPH or,\n  * Transfer to ICU level care due to PPH\n  * Significant PPH intervention, i.e. hysterectomy or arterial embolization Non-PPH\n  * QBL \\\u003C 500 mL and,\n  * No transfusion of blood products, and\n  * No need for elevated care environment, i.e. HAU or ICU\n\nExclusion Criteria:\n\n* Patients with pre-existing psychiatric disorders affecting recovery assessment.\n* Patients who experience severe obstetric complications other than PPH (e.g., eclampsia, uterine rupture).\n* Overdistended uterus due to; Polyhydramnios (amniotic fluid index \\>24 cm) or multiple gestation\n* History of previous PPH (documented with blood loss of \\>1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)\n* BMI \\> 50\n* Language barrier (English)",{"count":121,"type":21},152,"OBSERVATIONAL","Postpartum hemorrhage (PPH) remains a leading cause of maternal death and morbidity. Moreover, it also contributes to psychological trauma such as depression and post-traumatic stress disorder. The American College of Obstetrics and Gynecology (ACOG) and the Society for Maternal Fetal Medicine (SMFM) defines this morbidity as an unintended outcome in the birthing process that may have significant short-term and long-term consequences to an individual's health. A recent study in 2018 developed core outcomes set for PPH through Delphi consensus encompassing elements of prevention and management of PPH.\n\nPatient-reported outcomes, breastfeeding, and overall sense of wellbeing were not included in the final outcome set. Nevertheless, investigators felt strongly that they should be included, but further work was needed to assess the factors influencing the quality of recovery in the context of PPH. This is aligned with increasing recognition that patient experiences are important to improving the quality of care and quality of recovery after Cesarean delivery. The most effective, i.e. validated tool for assessing postpartum recovery is the Obstetric Quality of Recovery-10 (Obs-QoR-10). However its application in patients with PPH remains unexplored. It would appear logical that patient experiencing PPH experience a potentially more challenging recovery process which may include more surgical complications, depressive symptoms, sleep deprivation, physical exhaustion and stress due to unexpected and undesired delivery events. This study aims to compare Obs-QoR-10 scores in patients with and without PPH to evaluate the impact of severe postpartum bleeding on recovery outcomes using a matched case-control design.\n\nThe investigators plan to determine the differences in Obs-QoR-10 scores between patients who experience PPH during childbirth and those deliver without PPH, and to evaluate the impact of PPH on specific recovery domains (physical comfort, emotional well-being, and functional recovery).",[27],[126,127,128],"cesarean delivery","vaginal delivery","ObsQoR-10","2025-11-26",{"date":131,"type":47},"2025-11-28",{"date":133,"type":47},"2025-10-03",{"date":135,"type":21},"2026-07",{"name":82,"class":54},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":63,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":55},"100587592","effect-of-extracellular-calcium-on-carbetocin-mediated-contractility-in-human-myometrium-100587592","NCT06930391","Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium","Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium: An Ex-Vivo Study","Inclusion Criteria:\n\n* non-laboring women with gestational age between 37 to 41 weeks\n* not exposed to exogenous oxytocin, scheduled for a primary or first repeat cesarean delivery under neuraxial anesthesia.\n\nExclusion criteria:\n\n* patients requiring general anesthesia\n* more than 1 previous cesarean delivery\n* history of uterine atony\n* emergency cesarean section in labor\n* patients using medications that could affect myometrial contractility such as nifedipine, labetalol, or magnesium sulphate.\n* patients with any condition of predisposing to uterine atony and postpartum hemorrhage, such as abnormal placentation, multiple gestation, severe preeclampsia, macrosomia, polyhydroamnios, large uterine fibroids, chorioamnionitis, previous history of postpartum bleeding.","40 Years",{"count":146,"type":21},40,[24],"Postpartum hemorrhage (PPH) continues to be an increasing problem globally. Uterotonics play an essential role in the pharmacological management of uterine atony. Carbetocin, a long acting analog of oxytocin has been recommended as a first line uterotonic for PPH prophylaxis at cesarean delivery. Considering many woman have associated comorbidities and are at high risk of PPH, finding alternative pharmacological agents is essential. Calcium is a key factor for myometrial contractions and calcium blood levels can be low at the end of pregnancy. Both hypocalcemia and hypercalcemia could lead to a decrease in myometrial contractions. It is already been demonstrated that in both desensitized and naïve myometrium, normocalcemia provides a better uterine tone compared to hypo and hypercalcemia when oxytocin is given as the first uterotonic drug.\n\nCurrently, the role of extracelullar calcium in carbetocin- induced contractility is unknown. This will be the first ex vivo study to test the effects of extracellular calcium on oxytocin pretreated and naive myometrium. The results of this study will provide evidence on the use of this safe drug in clinical practice, particularly in women with labour arrest, and provide alternative pharmacological strategies to both prevention and treatment of PPH, thus improving our clinical practice.\n\nThe investigators hypothesize that extracellular normocalcemia would provide superior carbetocin-mediated contractility in both naive and oxytocin-pretreated myometrium compared with hypercalcemia and hypocalcemia.",[27],[72,71,151,126],"uterine contraction","2025-09-22",{"date":154,"type":47},"2025-09-24",{"date":156,"type":47},"2025-09-15",{"date":158,"type":21},"2026-06",{"name":82,"class":54}]