[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preterm-premature-rupture-of-membranes-pprom\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preterm-premature-rupture-of-membranes-pprom":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100601206","phase-3-tailored-therapeutic-regime-in-patients-with-preterm-premature-rupture-of-membranes-to-prolong-pregnancy-improve-maternal-and-neonatal-outcomes-and-reduce-antibiotic-burden-100601206",false,"NCT07107477","TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden","Prospective Randomized Controlled Trial to Evaluate if Tailored Antibiotic and Steroid Therapy Based on the Interleukin-6 (IL-6) Value in Amniotic Fluid Obtained by Amniocentesis in Patients With Premature Rupture of Membranes is Associated With Pregnancy Prolongation Compared to Standard Management.","TAILORED-PROM","Inclusion Criteria:\n\n* pPPROM Confirmed by Amnisure test1 and\u002For clinical signs of pPROM on examination (Clinical signs of pPROM: presence of visual pooling of amniotic fluid during sterile speculum examination)\n* Weeks of pregnancy 22+03 - 33+64\n* Singleton pregnancy\n* Signed informed consent form (ICF)\n* Completely uncomplicated pregnancy until the occurrence of pPROM\n\nExclusion Criteria:\n\n* active labour (uterine activity leading to cervical dilatation greater than 4 cm)\n* Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress\n* Multiple pregnancy\n* Pregnancy with chromosomal or severe morphological abnormality\n* Signs of chorioamnionitis at the admission (clinical and\u002For laboratory)\n* Patients with severe immunological compromise (immunodeficient)\n* Patients with an oncological disease\u002Fimmunosuppression\n* Patients with an active drug abuse\n* Non-compliant patients\n* Any contraindication according to the valid SmPC for the administered product","FEMALE","18 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn whether tailoring antibiotic and steroid treatment based on a lab result (interleukin-6, or IL-6) from amniotic fluid can help safely prolong pregnancy in people with preterm premature rupture of membranes (pPROM). This condition means the water breaks too early, before 37 weeks of pregnancy, which increases the risk of infection and early birth.\n\nThe main questions the study aims to answer are:\n\n1. Can using IL-6 levels to guide treatment help the pregnancy last more than 7 days after pPROM?\n2. Can this approach improve health outcomes for both the parent and the baby?\n\nResearchers will compare two groups:\n\n1. A tailored treatment group, where IL-6 levels from amniotic fluid help decide when to give steroids and antibiotics.\n2. A standard care group, where everyone receives the same treatment right after diagnosis.\n\nParticipants will:\n\n* Be screened to confirm pPROM and eligibility.\n* Be randomly assigned to one of the two groups.\n* Receive regular check-ups and monitoring in the hospital until delivery.\n* In the tailored group, have weekly amniocentesis (a safe procedure to collect amniotic fluid) if needed.\n\nThe study includes follow-up for 6 months after birth to track both the baby's and parent's health.\n\nThis research may help doctors better time treatments, reduce unnecessary use of medications, and improve outcomes for families facing pPROM.",[27],"Preterm Premature Rupture of Membranes (PPROM)","RECRUITING","2026-06-16",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":32},"2025-05-01",{"date":36,"type":21},"2028-05-01",{"name":38,"class":39},"The Central and Eastern European Gynecologic Oncology Group","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100635929","effects-of-emotional-freedom-technique-and-music-therapy-in-high-risk-pregnancy-100635929","NCT07559071","Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy","The Effect of Emotional Freedom Technique and Music Therapy Applied to High-Risk Pregnant Women on Maternal Psychological Status, Coping Methods, and Non-Stress Test Findings: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged 18 years and older\n* Able to speak and understand Turkish\n* Diagnosed with preterm premature rupture of membranes (PPROM)\n* Gestational age between 28+0 and 35+5 weeks\n* Score of ≥1 on the Subjective Units of Disturbance Scale (SUDS)\n* Singleton pregnancy\n* Able and willing to communicate and participate in the study\n\nExclusion Criteria:\n\n* Pregnancy achieved via assisted reproductive technologies\n* Presence of any obstetric complication other than PPROM\n* Presence of major fetal anomalies\n* Active labor at the time of recruitment\n* Hearing impairment\n* Presence of infection, wounds, or scars at tapping sites (for EFT application)\n* History of severe psychiatric disorder or currently receiving psychiatric treatment\n* Any maternal or fetal condition requiring emergency medical intervention",{"count":49,"type":21},177,[51],"NA","Pregnancy is a physiological process; however, it is also a dynamic period during which obstetric and medical complications that may threaten maternal and fetal health can occur. In the presence of such complications, pregnancy is defined as a high-risk pregnancy, accounting for approximately 10-20% of all pregnancies. Due to the increased risk of maternal and fetal morbidity and mortality, high-risk pregnancies are considered a significant public health issue.\n\nAmong high-risk pregnancies, premature rupture of membranes (PROM) and particularly preterm premature rupture of membranes (PPROM) are obstetric conditions associated with serious risks for maternal and perinatal outcomes. PPROM is responsible for a substantial proportion of preterm births and is associated with an increased risk of neonatal complications.\n\nDuring the course of PROM and PPROM, the latency period between membrane rupture and delivery constitutes a significant source of uncertainty and psychosocial burden for pregnant women. Factors such as prolonged hospitalization, risk of complications, and fear of fetal loss may lead to increased levels of stress, anxiety, and depression in this population.\n\nIn the face of intense stress and uncertainty, coping strategies emerge as an important determinant of psychological outcomes. Coping refers to the cognitive and behavioral efforts individuals employ to manage situations perceived as threatening and is generally classified into active and avoidant coping strategies. Avoidant coping strategies have been associated with higher levels of anxiety and depression, whereas adaptive coping strategies are reported to enhance psychological resilience.\n\nMaternal psychological status may influence not only the mother's mental health but also fetal well-being. In this context, the non-stress test (NST) is an important tool for evaluating fetal autonomic nervous system function and allows monitoring of the relationship between maternal psychological status and fetal physiological responses. However, findings regarding the relationship between maternal anxiety and depression and NST parameters remain inconsistent.\n\nCurrent clinical management of PROM and PPROM primarily focuses on preventing obstetric complications, while the maternal psychological dimension often remains secondary. Therefore, safe and feasible non-pharmacological interventions during pregnancy have gained increasing attention.\n\nEmotional Freedom Technique (EFT) and music therapy are among the non-pharmacological interventions shown to be effective in reducing stress, anxiety, and depression during pregnancy. However, no studies have been identified in the literature evaluating the effects of these interventions on maternal psychological status, coping strategies, and fetal well-being in high-risk pregnancy groups such as PROM and PPROM. Therefore, randomized controlled trials are needed to evaluate the effects of EFT and music therapy on maternal psychological status, coping strategies, and fetal well-being in pregnant women diagnosed with PPROM.",[27,54,55],"Premature Rupture of Membranes (PROM)","High-Risk Pregnancy",[57,58,55,59,60,61,62,63,64,65,66],"Emotional Freedom Technique","Music Therapy","PPROM","Maternal Mental Health","Anxiety","Depression","Stress","Coping Strategies","Non-Stress Test","Fetal Well-Being","NOT_YET_RECRUITING","2026-04-26",{"date":70,"type":32},"2026-04-30",{"date":72,"type":21},"2026-06-01",{"date":74,"type":21},"2027-03",{"name":76,"class":39},"Selcuk University"]