[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perinatal-morbidity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perinatal-morbidity":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,58,94],{"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":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":66,"minAge":18,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100528995","influenza--covid-19-obstetric-and-perinatal-epidemiology-study-in-india-100528995","NCT06168019","Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India","Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India","ICOPE","Inclusion Criteria:\n\nWomen aged 18 to 50 years registering for antenatal care (ANC) at Government Medical College Hospital (GMC) Nagpur, India\n\n* Estimated Gestational Age at registration \\\u003C14 weeks based on ultrasound report at the baseline study visit;\n* Intends to receive pregnancy, labor and delivery and neonatal care at GMC;\n* Plans to live within the city limits of Nagpur throughout their pregnancy and labor and delivery to facilitate access to GMC for evaluation of ILI and COVID-19 symptoms;\n* Willing to be contacted two times per week by call or text for ILI\u002F COVID-19 symptom screening and return to GMC for evaluation and an NP swab\u002Fevaluation if symptoms are reported;\n* Willing to take temperature with the provided digital thermometer, and maintain a symptom diary after training;\n* Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;\n* Willing to permit venous blood draws on at least 4 timepoints --1) Baseline study visit, 2)28-34 weeks, 3) 37 weeks - prior to delivery and 4) after delivery;\n* Willing to permit blood draws if hospitalized at GMC for COVID-19 infection;\n* Willing to consent to participate in the study\n\nExclusion Criteria:\n\n* Anyone who is deemed to have limited decision-making capacity as defined by Boston University IRB i.e. Substantial impairment of cognitive functions (e.g. attention, comprehension, memory, and intellect), or conditions that might affect their cognitive functions.\n* Anyone who is deemed to have limited capacity to consent as defined by Boston University Institutional Review Board (IRB) i.e. The ability to provide legally effective consent to enroll in a research study (AAHRPP definition).","FEMALE","50 Years",{"count":69,"type":21},10000,"OBSERVATIONAL","This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.",[73,74,75,76,29,77],"Influenza","COVID-19","SARS-COV-2 Infection","Other Respiratory Viruses","Infant Morbidity",[79,80,81,82,83],"Pregnant women","Government Medical College Hospital, Nagpur, India","Covid-19 vaccination","Antenatal care","Postpartum","2025-11-26",{"date":86,"type":50},"2025-11-28",{"date":88,"type":50},"2023-12-26",{"date":90,"type":21},"2028-06",{"name":92,"class":56},"Boston University",2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":66,"minAge":18,"maxAge":67,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":93},"100537067","improving-intrapartum-care-for-saving-life-at-birth-in-ethiopia-through-partoma-approach-100537067","NCT06273007","Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach","Introducing PartoMa Approach to Ethiopia for Improving Intrapartum Care and Maternal Survival: The Case of the Ethiopian Obstetric Surveillance System (PartoMa-Ethiopia)","PartoMa-Eth","Inclusion Criteria:\n\n* All women in labour delivering at the study site and their outcome, July - September 2023 and July -September 2025\n* All birth attendant at the study site in obstetrics and gynecology departments during the baseline and intervention period, July - September 2023 and July -September 2025\n\nExclusion Criteria:\n\n* NA",{"count":103,"type":21},500,[24],"Overall Objective\n\nTo introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.\n\nInterventions\n\n1. Locally agreed and achievable intrapartum guidelines\n2. Low dose high frequency trainings (LDHF)\n3. Partograph Overall Design\n\nA quasi-experimental pre-post study (PartoMa study)\n\nSetting\n\nDepartment of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.\n\nPopulation\n\nLaboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at\u002Fafter onset of labour and followed until discharge.\n\nEndpoints\n\nThe primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.\n\nStudy Time\n\nData collection from June 2023 to May 2025.\n\nSpecific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.\n\niii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.\n\niv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.\n\nSetting\n\nPartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000.",[107,108,109,37,29],"Stillbirth","Obstetric Complication","Maternal Death",[111,112,113,114,115,116,117],"Obstetrics","perinatal","maternal","Intrapartum","Quality","PartoMa","LDHF","2024-02-15",{"date":120,"type":50},"2024-02-22",{"date":122,"type":50},"2023-06-01",{"date":124,"type":21},"2027-12-31",{"name":126,"class":56},"Haramaya Unversity"]