[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Samuel Lunenfeld Research Institute, Mount Sinai Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":354},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,60,88,114,137,158,179,199,219,245,268,288,314,332],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100644265","hyperangulated-vs-macintosh-style-blades-for-intubation-in-obstetric-patients-100644265",false,"NCT07667010","Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients","HyperANGulated Versus Macintosh styLE blaDes for INtubation in OBstetric Patients: a Cluster Randomized Feasibility Study","ANGLED","Inclusion Criteria:\n\n1\\. Pregnant patients undergoing emergency or urgent cesarean delivery under general anesthesia requiring tracheal intubation.\n\nExclusion Criteria:\n\n1. No tracheal intubation performed and (ii) patient refusal of consent.\n2. Patients not receiving general anesthesia.\n3. Patients that previously participated in the study.","FEMALE",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","Cesarean section under general anesthesia requires intubation (insertion of a tube through the mouth into the breathing pipe to support breathing during the surgery). A device called a video laryngoscope is used, which has a smooth, curved, or less curved component called 'a blade' that helps the doctor gently see the voice box and guide the breathing tube safely into place during anesthesia; it is not a sharp tool blade.\n\nThere are two types of video laryngoscopes blades: a Macintosh- style blade with a gentle curve, approximately 90 degrees) and a hyperangulated blade (with a more pronounced curve).\n\nAlthough video laryngoscopes are safe and both types have been used for around 20 years, it is not known whether one type works better that the other in patients undergoing cesarean delivery under general anesthesia. Because general anesthesia is used in only a small proportion (about 5%) of all cesarean deliveries, research in this area is limited.\n\nThe main purpose of the study is to assess if a study comparing these two types of blades in the obstetric population is feasible. This is also known as a feasibility study, which aims to test the study plan and determine whether enough participants will join a larger study and accept the study procedures. The results will be used as a guide for a larger study.",[26,27,28,29,30,31,32,33,34],"Obstetric","Cesarean Birth","Airway Anesthesia","Intubation","General Anesthesia; Tracheal Intubation","Video Laryngoscopy","Obstetric Anesthesia","Obstetric Anesthesia Problems","General Anesthesia",[36,37,38,39,40,41,42,43,44,45,46],"obstetric","obstetric anesthesia","intubation","airway safety in OB patients","video laryngoscopy","cesarean delivery","general anesthesia in cesarean delivery","macintosh blade","hyperangulated blade","intubation in OB patients","general anesthesia","NOT_YET_RECRUITING","2026-06-19",{"date":50,"type":51},"2026-06-24","ACTUAL",{"date":53,"type":20},"2026-06-15",{"date":55,"type":20},"2028-06-30",{"name":57,"class":58},"Samuel Lunenfeld Research Institute, Mount Sinai Hospital","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":59},"100632629","a-digital-educational-resource-to-improve-preparedness-for-shared-decision-making-about-labour-analgesia-100632629","NCT07516171","A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia","A Randomized Controlled Trial of a Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia","PrepDM","Inclusion Criteria:\n\n* Pregnant individuals ≥ 18 years\n* Visiting OB clinic at Mount Sinai hospital during their 3rd trimester of pregnancy (≥ 28 weeks gestation)\n* Singleton gestation\n* Nulliparous\n* Considering labour epidural analgesia for childbirth\n\nExclusion Criteria:\n\n* Sensory, cognitive, or language barriers precluding participation\n* Limited English proficiency",true,"18 Years","55 Years",{"count":72,"type":20},200,[23],"Labour analgesia decisions are often made under time pressure, while in pain, which may lead patients to feel unprepared or uninformed. Shared decision-making (SDM) enhances patient satisfaction, promotes alignment with personal values, and improves trust in clinical care. Digital tools can support SDM by providing accessible, evidence-based information.\n\nThe Society for Obstetric Anesthesia and Perinatology (SOAP) is an international organization made up of doctors who specialize in managing pain and anesthesia during pregnancy. Their focus is the wellbeing and safety of mothers and their babies from early pregnancy through delivery and recovery. The Painless Push digital resource educates mothers about ways to manage pain during labour.\n\nThis trial aims to evaluate whether directing patients to access to the website https:\u002F\u002Fthepainlesspush.com\u002F improves preparedness for shared decision-making compared to the current care, which is access to the Mount Sinai Obstetric Anesthesia website.",[76],"Labour Analgesia",[78,79],"labour pain","education","2026-04-14",{"date":82,"type":51},"2026-04-17",{"date":84,"type":20},"2026-04",{"date":86,"type":20},"2026-12",{"name":57,"class":58},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":113,"locationsCount":59},"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.","45 Years",{"count":97,"type":20},120,[23],"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.",[101],"Postpartum Hemorrhage (Primary)",[103,104,105],"calcium","carbetocin","cesarean","RECRUITING","2026-03-31",{"date":109,"type":51},"2026-04-01",{"date":111,"type":51},"2025-12-01",{"date":86,"type":20},{"name":57,"class":58},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":136,"locationsCount":59},"100560061","quality-of-labour-epidural-analgesia-with-intrathecal-morphine-as-a-component-of-combined-spinal-epidural-100560061","NCT06572241","Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural","Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural: a Double-blinded Randomized Control Trial","Inclusion Criteria:\n\n* Adult (≥18 years) term primiparous (≥37 weeks) patients with live singleton pregnancy\n* Patients who request labour analgesia and do not have any contraindications for neuraxial analgesia.\n* Less than or equal to 6 cm cervical dilation during the last vaginal examination.\n\nExclusion Criteria:\n\n* Patients who are expected to be discharged within 24 hours of delivery.\n* Patients with chronic pain conditions, opioid use disorder, pre-gestational diabetes, obstructive sleep apnea, morbid obesity (BMI \\>40 kg\u002Fm2), or fetal abnormalities.\n* Patients who have intramuscular morphine within 12 hours or fentanyl \\>200 mcg in the preceding 4 hours.\n* Participants will be excluded from further analysis in case of spinal analgesic failure\n* Participants will be excluded from further analysis if labour lasts less than 2 hours","50 Years",{"count":123,"type":20},182,[23],"Neuraxial analgesia has shown to be the gold standard for effective labor pain relief, offering numerous benefits including enhanced pain control and maternal satisfaction. The methods to achieve neuraxial analgesia include lumbar epidural (LE), and combined spinal epidural (CSE). While LE may not consistently provide optimal pain relief, leading to frequent maternal requests for supplemental analgesics, CSE presents a promising advancement. This is due to the rapid onset of pain relief from intrathecal components, complemented by the longer-lasting effects of epidural medications. Intrathecal drugs have demonstrated the ability to offer more symmetrical blockades compared to epidurally administered medications. Nonetheless, some clinicians remain cautious about CSE due to the potential for increased pain when transitioning from spinal to less effective epidural analgesia. Long-acting opioids like morphine in the intrathecal space may mitigate this problem by providing transitional analgesia to the laboring parturient.\n\nThe primary aim of this randomized controlled trial is to provide evidence of whether the addition of 100 mcg of morphine in the intrathecal (spinal) component of CSE reduces the rate of breakthrough pain during labor.",[127],"Labor Pain",[129,130,131],"combined spinal epidural","CSE","intrathecal morphine",{"date":109,"type":51},{"date":134,"type":51},"2024-11-20",{"date":86,"type":20},{"name":57,"class":58},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":121,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":157,"locationsCount":59},"100541705","comparative-efficacy-of-carbetocin-and-oxytocin-in-parturients-at-risk-of-atonic-postpartum-hemorrhage-undergoing-elective-cesarean-delivery-100541705","NCT06333340","Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery","Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial","Inclusion criteria - Any one or more of the risk factors for uterine atony:\n\n* Overdistended uterus due to:\n\n  * Polyhydramnios (amniotic fluid index \\>24 cm)\n  * Fetal macrosomia reported on prenatal ultrasound \\>90th centile or \\> 4000 gm\n  * Multiple gestation\n* History of uterine atony\u002FPPH (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* Obesity with body mass index (BMI) \\>40 kg\u002Fm2\n* Diabetes mellitus on treatment\n* Preeclampsia on treatment\n* Placenta previa\n\nExclusion criteria:\n\n* Valvular heart disease, arrhythmias, or heart failure\n* Placenta accreta spectrum\n* Bleeding disorder\n* Anemia (\\\u003C100 g\u002Fdl)\n* Allergy or sensitivity to oxytocin or carbetocin",{"count":145,"type":20},160,[23],"The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.\n\nThis trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.\n\nThe investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.",[149],"Post Partum Hemorrhage",[151,104,41,152],"oxytocin","pregnancy",{"date":109,"type":51},{"date":155,"type":51},"2025-01-14",{"date":86,"type":20},{"name":57,"class":58},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":95,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":178,"locationsCount":59},"100538021","comparing-the-dose-response-profiles-of-uterotonics-after-initial-carbetocin-administration---an-ex-vivo-study-in-desensitized-human-myometrium-100538021","NCT06285409","Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium","Inclusion criteria\n\n* Patients who give written consent to participate in this study\n* Patients with gestational age 37-41 weeks\n* Non-laboring patients, not exposed to exogenous oxytocin\n* Patients requiring elective primary or first repeat CD\n* Patients undergoing CD under spinal anesthesia\n\nExclusion criteria\n\n* Patient refusal\n* Patients who require general anesthesia\n* Patients in labour and those receiving oxytocin for induction of labour\n* Emergency CD\n* placenta accreta spectrum disorder\n* Patients who have had previous uterine surgery or \\>1 previous CD\n* Patients with any condition predisposing to uterine atony and PPH (BMI \\> 40 kg\u002Fm2,\n* Patients on medications that could affect myometrial contractility, such as insulin, nifedipine, labetalol or magnesium sulphate.",{"count":165,"type":20},32,[23],"This study will investigate the effects of drugs called \"uterotonics\" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called \"uterine atony\", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered.\n\nThis study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further.",[169],"Postpartum Hemorrhage",[104,171,151,172],"duratocin","uterine contraction",{"date":174,"type":51},"2026-04-06",{"date":176,"type":51},"2024-04-04",{"date":86,"type":20},{"name":57,"class":58},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":68,"sex":17,"minAge":185,"maxAge":95,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":198,"locationsCount":59},"100538020","effect-of-ephedrine-phenylepinephrine-and-norepinephrine-on-myometrial-contractility-in-pregnant-people-with-type-ii-and-gestational-diabetes-during-cesarean-section-an-in-vitro-study-100538020","NCT06285396","Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study","Inclusion Criteria:\n\n* Patients who have given consent to participate in the study\n* Patients with gestational age 37-41 weeks\n* Patients previously diagnosed with either Type II or Gestational diabetes. For the healthy control group, no previous diagnosis is required for inclusion\n* Patients of 19-45 years\n* Patients of normal BMI (18-30 BMI) for the healthy control group only\n* Baby is registered as normal weight for size for the healthy control group only\n* Non-laboring patients, not exposed to exogenous oxytocin\n* Patients requiring elective primary or first repeat caesarean delivery\n* Patients undergoing caesarean delivery under spinal anesthesia\n\nExclusion Criteria:\n\n* Patients who refuse to give written informed consent\n* Patients who require general anesthesia\n* Patients in labor and those receiving oxytocin for induction of labor\n* Emergency caesarean delivery in labor\n* Patients who have had previous uterine surgery involving myometrial dissection or \\>1 previous caesarean delivery\n* Patients with risk factors for PPH such as those with polyhydramnios, preeclampsia, multiple gestation, morbid obesity, macrosomia (large for size baby), and previous history of PPH. However, for diabetic group, those with morbid obesity and macrosomia will not be excluded as these conditions are almost always associated with diabetes.\n* For the healthy control group only, a BMI \\>30 or \\\u003C18\n* Maternal age \\>45","19 Years",{"count":187,"type":20},96,[23],"The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes.\n\nSpinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH.\n\nIt is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory.",[169],[151,192,193,172],"type II diabetes","gestational diabetes",{"date":174,"type":51},{"date":196,"type":51},"2024-03-18",{"date":86,"type":20},{"name":57,"class":58},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":121,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":218,"locationsCount":59},"100461551","oxytocin-maintenance-infusion-in-labouring-women-undergoing-cesarean-delivery-an-up-down-sequential-allocation-study-100461551","NCT05290129","Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study","Inclusion Criteria:\n\n• All patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia (at least 3 hours of prior exposure to oxytocin during labour)\n\nExclusion Criteria:\n\n* All patients who refuse to give written informed consent\n* All patients who declare allergy or hypersensitivity to oxytocin\n* A history of hypertension and\u002For severe cardiac disease(s)\n* All patients who have contraindications for neuraxial anesthesia\n* All patients who will be converted to general anesthesia intraoperatively\n* All patients with placenta previa and multiple gestation",{"count":206,"type":20},40,[23],"This study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. Consequently, it will help to reduce blood loss after delivery. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. The next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. If the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. If the response is not satisfactory, then the infusion dose will increase for the next patient. The dose for each patient will be determined based on the results of the uterine contraction of the previous patient.\n\nThe investigators hypothesize that the ED90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 IU\u002Fmin (44 IU\u002Fh), which was found as the ED90 in a previous study, without an initial bolus dose prior to the infusion.",[169],[211,151,212,152,213],"Cesarean delivery","uterotonic","labour",{"date":174,"type":51},{"date":216,"type":51},"2022-08-17",{"date":86,"type":20},{"name":57,"class":58},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":68,"sex":17,"minAge":185,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":59},"100366608","effects-of-ephedrine-phenylephrine-norepinephrine-and-vasopressin-on-contractility-of-human-myometrium-and-umbilical-vessels-an-in-vitro-study-100366608","NCT04053478","Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study","Inclusion Criteria:\n\n* Patients who give written consent to participate in this study\n* Patients with gestational age 37-41 weeks\n* Patients of 19-40 years\n* Non-laboring patients, not exposed to exogenous oxytocin\n* Patients requiring elective primary or first repeat caesarean delivery\n* Patients undergoing caesarean delivery under spinal anesthesia\n\nExclusion Criteria:\n\n* Patients who refuse to give written informed consent\n* Patients who require general anesthesia\n* Patients in labor and those receiving oxytocin for induction of labor\n* Emergency caesarean delivery in labor\n* Patients who have had previous uterine surgery or \\>1 previous caesarean delivery\n* Patients with any condition predisposing to uterine atony\n* Patients on medications that could affect myometrial contractility, such as insulin, nifedipine, labetolol or magnesium sulfate.","40 Years",{"count":227,"type":20},144,[23],"Hypotension is one of the most common adverse effects of spinal anesthesia for cesarean deliveries, affecting as many as 55-90% of mothers. Hypotension during cesarean deliveries can have detrimental effects on the mother and neonate. Various vasopressors, such as ephedrine, phenylephrine and more recently norepinephrine, have been used for the prevention and treatment of hypotension at cesarean deliveries.\n\nEphedrine was historically considered as the gold standard vasopressor for the management of hypotension during cesarean deliveries. This was based on studies in animal models that showed preserved uteroplacental circulation with ephedrine and not with phenylephrine. However, multiple studies in the past several decades have shown that phenylephrine compared with ephedrine results in a more favorable fetal acid-base status. Consequently, the use of phenylephrine for blood pressure management during cesarean deliveries increased. Recently, norepinephrine was introduced in the obstetrical practice for the management of hypotension at cesarean deliveries, due to its ability to maintain maternal cardiac output better than phenylephrine.\n\nStudies have also investigated the use of vasopressin to limit hypotension during CD. There have been case reports of successful vasopressin usage to treat post-spinal hypotension after CD in patients with advanced idiopathic pulmonary arterial hypertension as well as severe mitral stenosis with pulmonary hypertension. Its effect was associated with hemodynamic stability without evidence of harm to the mother or child. However, much controversy still exists surrounding the choice of vasopressor in the obstetric population, in large part due to their varying efficacies, and maternal and fetal effects.\n\nVasopressors used for the treatment of hypotension during cesarean deliveries can have significant direct or indirect effects on the perfusion of uteroplacental and umbilical vessels. Reduction of uteroplacental perfusion and constriction of umbilical vessels can result in fetal acidosis, however, the mechanisms for these effects are unclear. The investigators hypothesize that ephedrine, phenylephrine and norepinephrine and vasopressin have variable effects on the contractility of pregnant myometrium and umbilical arteries due to their variable actions on adrenergic alpha (α) and beta (β) receptors, as well as vasopressin1 and vasopressin2 receptors located in these tissues.",[231],"Hypotension",[233,234,235,236,237,172,238,239],"vasopressor","ephedrine","phenylephrine","norepinephrine","umbilical arteries","fetal acidosis","vasopressin",{"date":174,"type":51},{"date":242,"type":51},"2019-07-08",{"date":86,"type":20},{"name":57,"class":58},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":59},"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":253,"type":20},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).",[101],[41,258,259],"vaginal delivery","ObsQoR-10","2025-11-26",{"date":262,"type":51},"2025-11-28",{"date":264,"type":51},"2025-10-03",{"date":266,"type":20},"2026-07",{"name":57,"class":58},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":225,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":59},"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.",{"count":206,"type":20},[23],"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.",[101],[104,103,172,41],"2025-09-22",{"date":282,"type":51},"2025-09-24",{"date":284,"type":51},"2025-09-15",{"date":286,"type":20},"2026-06",{"name":57,"class":58},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":121,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":59},"100566476","changes-in-velocimetric-indices-of-uterine-and-umbilical-arteries-before-and-after-combined-spinal-epidural-analgesia-in-laboring-women-part-ii-100566476","NCT06655675","Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART II)","Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART I and PART II)","Inclusion Criteria:\n\n* Written informed consent\n* Term pregnant patients requesting labor analgesia\n* Singleton pregnancy\n* Term pregnant patients in active labor\n* ASA\\\u003C4\n* No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE\n* Patients with and without diagnosed hypertensive disorders of pregnancy\n\nExclusion Criteria:\n\n* Refusal to consent for the study\n* Known spinal deformities\n* Previous back instrumentation\n* Patients with BMI\\>50 kg\u002F㎡ due to anticipated technical challenges in Doppler studies",{"count":296,"type":20},54,[23],"Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block.\n\nMaternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships.\n\nThe investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.",[127],[301,302,303,304,305],"combined spinal epidural (CSE)","fetal bradycardia","ultrasound","velocimetric index","hypertension","2025-07-10",{"date":308,"type":51},"2025-07-11",{"date":310,"type":51},"2024-10-30",{"date":312,"type":20},"2026-01",{"name":57,"class":58},{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":68,"sex":17,"minAge":69,"maxAge":70,"enrollmentInfo":320,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":331,"locationsCount":59},"100516303","evaluation-of-patient-reported-outcomes-measurement-information-system-promis-29-v21-for-postpartum-women-100516303","NCT06002763","Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women","Inclusion Criteria:\n\n* 18 years old and over\n* singleton births\n* 37 or more weeks gestational age\n* multiparous or nulliparous patients\n* spontaneous vaginal delivery or scheduled cesarean delivery with labor analgesia or neuraxial anesthesia\n* give informed written consent\n\nExclusion Criteria:\n\n* refusal to take part\n* are unable to give or have withdrawn consent\n* patients unable to communicate fluently in English\n* patients who are less than 18 years old\n* patients who had fetal demise or severely morbid fetal conditions such as intubation, cooling, expected surgical correction of congenital anomaly during hospitalization (although NICU admissions will be included)\n* patients who were admitted in ICU\n* patients who had failed neuraxial analgesia such as replaced epidurals or failed spinal requiring conversion to general anesthesia\n* patients who had general anesthesia for cesarean delivery as defined by \"GETA\", including sedatives and deep sedation if not intubated\n* patients who had intrapartum cesarean or had assisted\u002Foperative (i.e. vacuum, forceps) vaginal delivery.",{"count":72,"type":20},"There is no widely used, statistically validated assessment for physical and mental health for the short- to medium-term in a postpartum population. PROMIS-29 has been validated for the assessment of these factors in a generic population, but has not been specifically evaluated for use with postpartum women.\n\nThis study is a longitudinal, single center observational cohort study designed to evaluate the reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 survey in a postpartum population. PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living. While this survey has shown utility in other populations, it has yet to be assessed in an obstetric population. The investigators plan to recruit patients who are recently postpartum from vaginal or cesarean delivery to complete virtual surveys at defined time points (0, 2, 6, and 12 weeks after delivery). The investigators will subject survey data to statistical measures of validity and reliability comparing with contemporaneously collected surveys of established metrics for quality of life (WHOQoLBREF) and general (global) state of health (numerical rating score 1-100).\n\nThe hypothesis is that the PROMIS-29 v2.1 questionnaire is a statistically valid and reliable means of assessing physical and mental health in a postpartum population.",[323],"Well-Being, Psychological",[41,258,325],"postpartum recovery",{"date":327,"type":51},"2025-07-15",{"date":329,"type":51},"2025-07-09",{"date":266,"type":20},{"name":57,"class":58},{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":340,"minAge":4,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":59},"100540582","modified-deep-extubation-vs-standard-awake-extubation-100540582","NCT06318715","Modified Deep Extubation vs. Standard Awake Extubation","A Comparison of a Modified Deep Extubation to Standard Awake Extubation for Decreasing Operating Room Time: a Randomized Controlled Trial","mDE","Inclusion Criteria:\n\n* ASA I-III\n* laparoscopic surgery under general anesthesia\n\nExclusion Criteria:\n\n* High-risk patients:\n\n  * Documented difficult airway during intubation or developed intraoperatively.\n  * Full stomach\n  * Pregnant women\n  * Emergency surgery\n  * BMI\\>30\n  * Intraoperative bleeding leading to transfusion\n* Use of remifentanil during extubation\n* Requirement for prone position for surgical approach (i.e., spine surgery, anal fistulectomy, tumor resection of the back, etc)\n* Absolute indication for awake or deep extubation\n* Use of opioids in chronic pain patients","ALL",{"count":342,"type":20},60,[23],"The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation. This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction. As previously stated, the literature shows that the risks of DE are equivalent to those of regular AE practice. Our hypothesis is that mDE will shorten the time from the end of the surgery (completion of last stitch) to the moment the patient is ready to leave the OR by at least 5 minutes when compared to standard AE practice.",[346],"Extubation","2025-07-03",{"date":329,"type":51},{"date":350,"type":51},"2024-04-08",{"date":352,"type":20},"2026-12-30",{"name":57,"class":58},""]