[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"maternal-morbidity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:maternal-morbidity":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"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":40,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100614048","amnioinfusions-protective-effects-on-respiratory-and-longitudinal-pediatric-outcomes-after-intrapartum-thick-meconium-exposure-100614048",false,"NCT07274527","Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","The PEARL Trial: A Randomized Trial of Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure","PEARL","Inclusion Criteria:\n\n* Maternal age greater than or equal to 18 years old\n* Singleton pregnancy\n* Gestational age of greater than or equal to 36 weeks 0 days gestation\n* Cephalic presentation\n* Cercial dilation between 2-10 centimeters\n* Meconium\n\nExclusion Criteria:\n\n* Major fetal anomaly\n* Multiple gestation\n* Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing\n* Contraindication to internal monitors\n* Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent","ALL","18 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"NA","Thick meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension.\n\nAlthough amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly thick.\n\nThe PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop thick meconium-stained amniotic fluid, confirmed using a simple, objective measurement (\"meconium-crit\"). Participants will be randomly assigned to receive either:\n\nWarm lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion.\n\nThe main goal is to determine whether warm LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice.\n\nBy using a clear definition of thick meconium, a warm LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Neonatal Respiratory Distress Related Conditions","Meconium","Perinatal Morbidity","Neonatal Acidosis","Cord Blood","Neonatal Brain Injury","Maternal Morbidity","Mechanical Ventilation","CPAP","Surfactant","Perinatal Death","Amnioinfusion","NICU Admission",[38,28,41,42,33,43,44,45],"Neonatal morbidity","Developmental Screening","Neonatal respiratory morbidity","Umbilical cord gas and biomarkers","Healthcare Utilization","RECRUITING","2026-05-15",{"date":49,"type":50},"2026-05-19","ACTUAL",{"date":47,"type":50},{"date":53,"type":21},"2030-04-15",{"name":55,"class":56},"Medical College of Wisconsin","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":57},"100588482","partnering-with-antenatal-navigators-to-transform-health-in-pregnancy-100588482","NCT06941974","Partnering With Antenatal Navigators to Transform Health in Pregnancy","PATH","Inclusion Criteria:\n\n* Singleton gestation \\\u003C20 weeks of gestation\n* Nulliparous: no prior pregnancies ≥20 weeks excluding terminations\n* Low income (public insurance or residence in a neighborhood in which \\>10% of household incomes are \\\u003C125% of federal poverty line\n* Ability to speak and read English or Spanish\n* Established patient at one of practices associated with Northwestern Medical Group\n* Age 16 years or older\n\nExclusion:\n\n* Intent to transfer care to an outside institution\n* Prior enrollment in PATH\n* Concurrent enrollment in a study with competing aims\u002Fintervention","FEMALE","16 Years","50 Years",{"count":69,"type":21},600,[24],"The Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) study aims to evaluate whether an antenatal patient navigation program improves maternal health, neonatal health, pregnant women's experiences, and health care utilization outcomes among low-income pregnant women and their neonates. Patient navigation is an individualized, barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. In this randomized controlled trial, pregnant women who are randomized to receive antenatal patient navigation will be compared to pregnant women who are randomized to receive usual care. Navigators will support pregnant women from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing factors that influence health and access to care in order to promote self-efficacy, enhance access, and sustain long-term engagement.\n\nThe main objectives of the study are to:\n\n1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of antenatal patient navigation for low-income women will reduce the incidence of a composite of adverse maternal outcomes, all of which are known to be increased among women with barriers to care.\n2. Evaluate whether PATH, compared to usual care, improves perinatal health outcomes. We hypothesize PATH will reduce the incidence of a composite of adverse perinatal outcomes. We will also investigate neonatal\u002Fpediatric health care utilization.\n3. Evaluate patient, clinician, navigator, and healthcare system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim will be accomplished through investigating patient-reported outcomes, completing qualitative and process mapping interviews with navigated participants, and completing qualitative and process mapping interviews with clinicians, navigators, and health administrators.",[33,73,74,75,76],"Antenatal Health","Neonatal Morbidity","Retention in Care","Prenatal Care","2026-04-02",{"date":79,"type":50},"2026-04-06",{"date":81,"type":50},"2025-10-06",{"date":83,"type":21},"2030-06-01",{"name":85,"class":56},"Northwestern University"]