[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pregnancy-preterm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pregnancy-preterm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100459604","the-periviable-goals-decision-support-tool-100459604",false,"NCT05264779","The Periviable GOALS Decision Support Tool","Promoting Shared Decision Making in Periviable Care: A Randomized Controlled Trial of the Periviable GOALS Decision Support Tool","Inclusion Criteria for Pregnant Persons:\n\n* Adults (18 years or older)\n* Pregnant between 22 0\u002F7 to 25 6\u002F7 weeks gestation (this window may be slightly different for each recruitment site, as the gestational window that defines periviable delivery varies by institution).\n* Presenting to Labor \\& Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction).\n* Must have been counseled on their neonatal treatment options (e.g. resuscitation, comfort care) by their healthcare team prior to being approached by the study team.\n\nInclusion Criteria for Important Others:\n\n* Adults (18 years or older)\n* 1 per pregnant person\n* Is identified by the pregnant person as someone who will be involved in making decisions for the baby\n* Must be present at the time of randomization to participate\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Incarcerated\n* Medically unstable (i.e. in active labor and dilated 6cm or more)\n* Emotionally unstable\n* Have not been counseled by their healthcare team regarding neonatal treatment options\n* Are not admitted to Labor \\& Delivery for reasons indicative of a threatened early delivery\n* If they are experiencing a known fatal fetal anomaly\n* Are not present at the time of randomization (only for important others)","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0\u002F7 - 25 6\u002F7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.",[26,27,28,29,30],"Pregnancy Preterm","Premature Birth","Pregnancy Complications","Obstetric Labor, Premature","Obstetric Labor Complications",[32,33,34,35,36],"Decision making","Periviable delivery","Preterm birth","Risk Communication","Neonatal Resuscitation","RECRUITING","2026-05-06",{"date":40,"type":41},"2026-05-11","ACTUAL",{"date":43,"type":41},"2022-06-06",{"date":45,"type":20},"2027-02",{"name":47,"class":48},"Indiana University","OTHER",12,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100489302","phase-3-antenatal-melatonin-supplementation-for-neuroprotection-in-fetal-growth-restriction-100489302","NCT05651347","Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction","A Triple-blinded, Randomized, Parallel-group Placebo-controlled Trial to Assess the Impact of Maternal Antenatal Melatonin Supplementation on Early Childhood Neurodevelopmental Outcomes in the Setting of Severe Preterm Fetal Growth Restriction","PROTECTMe","Inclusion Criteria:\n\n1. Singleton Pregnancy\n2. Severe fetal growth restriction, defined as:\n\n   * Abdominal circumference ≤3rd centile for gestational age according to charts supplied that have been adapted from Westerway et al; or\n   * Abdominal circumference \\\u003C10th centile in combination with at least one abnormal fetoplacental Doppler study, being:\n\n     * Uterine artery (raised pulsatility index ≥95th centile)\n     * Umbilical artery (pulsatility index ≥95th centile or absent\u002Freversed end-diastolic flow)\n3. Confirmed 23+0 - 31+6 weeks' gestation\n4. Age ≥18 years\n5. Understand English\n\nExclusion Criteria:\n\n1. A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction\n2. Pregnancies requiring immediate delivery (e.g. absent A wave in ductus venosus, preterminal CTG or biophysical profile)\n3. Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement impacting on oxidative stress is the trial intervention.\n4. Currently prescribed Fluvoxamine",true,"FEMALE",{"count":61,"type":20},336,[63],"PHASE3","Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child.\n\nIt is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia.\n\nThis triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.",[66,67,26],"Fetal Growth Retardation","Stillbirth and Fetal Death","2025-06-03",{"date":70,"type":41},"2025-06-06",{"date":72,"type":41},"2019-05-29",{"date":74,"type":20},"2027-04-30",{"name":76,"class":48},"Monash University",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":58,"sex":59,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":5},"100524546","oral-health-and-adverse-pregnancy-complications-100524546","NCT06110143","Oral Health and Adverse Pregnancy Complications","The Prevention of Adverse Pregnancy Outcomes by Periodontal Treatment (PROBE) Intervention Study","Inclusion Criteria:\n\n* Pregnant women who are planned to give birth at either Holbaek or Nykoebing Falster hospital\n* Pregnant women diagnosed with periodontitis (stage I-III) by the study dentist\n\nExclusion Criteria:\n\n* Pregnant women without peridontitis\n* Pregnant women with less than 20 healthy teeths\n* Pregnant women with peridontitis and currently receiving treatment for peridontitis\n* Pregnant women with peridontitis stage IV","16 Years","48 Years",{"count":87,"type":20},600,[23],"Pregnant women are susceptible to develop periodontitis, but these oral health changes related to pregnancy are often neglected. Periodontitis is accompanied by a low-grade systemic inflammation and can be harmful to the general health of the woman, contribute to pre-term birth and adversely influence the future health and metabolism of the offspring. Despite this, studies indicate that 40% of Danish women in childbearing age do not visit a dentist regularly. The PROBE controlled intervention study will investigate the beneficial effect of treatment of periodontal disease during pregnancy on fetal growth, preterm delivery and birth weight.",[91,28,26,92,93,94],"Periodontal Diseases","Gestational Diabetes","Preeclampsia","Inflammation","2025-03-25",{"date":97,"type":41},"2025-03-30",{"date":99,"type":41},"2021-11-13",{"date":101,"type":20},"2026-05",{"name":103,"class":48},"University Hospital Bispebjerg and Frederiksberg"]