[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"South China Normal University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100617121","prenatal-exercise-including-perineal-massage-and-maternal-neonatal-outcomes-100617121",false,"NCT07314502","Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes","Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes: A Randomized Controlled Trial","PEPM-RCT","Inclusion Criteria:\n\n* Age ≥ 18 years；\n* Gestational age between 8 and 16 weeks\n* No contraindications to exercise；\n* Able to attend in-person exercise classes；\n* Having obtained hospital approval to participate in this exercise program；\n* Able to carry out basic communication in Mandarin Chinese;\n* Planning to deliver at the same maternal and child health hospital.\n\nExclusion Criteria:\n\n* Unable to deliver at the same hospital due to personal reasons；\n* Currently participating in other research projects；\n* Presence of absolute contraindications to exercise；\n* Uncertain about being able to attend three in-person exercise sessions per week；\n* Unable to communicate in Mandarin Chinese.",true,"FEMALE","18 Years",{"count":21,"type":22},2000,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study is divided into three phases:\n\nPhase 1: Baseline survey to obtain an overall understanding of the current situation of voluntary participation in prenatal perineal massage.\n\nPhase 2: Follow-up survey to further assess the current situation of voluntary prenatal exercise and prenatal perineal massage.\n\nPhase 3: Implementation of an intervention combining prenatal exercise and perineal massage.\n\nThe goal of this clinical trial is to learn whether a combined prenatal program of supervised, moderate-intensity exercise plus professionally administered antenatal perineal massage can improve maternal and newborn outcomes and can be safely implemented as part of routine antenatal care in healthy pregnant women receiving care at participating hospitals.\n\nThe main questions it aims to answer are:\n\n1. Does the combined prenatal program reduce urinary incontinence during pregnancy and after delivery?\n2. Does the combined prenatal program reduce depressive symptoms during pregnancy and in the postpartum period?\n3. Does the combined prenatal program lower the risk of gestational diabetes mellitus?\n4. Does the combined prenatal program reduce neonatal complications, including macrosomia?\n5. Do spontaneous, self-initiated prenatal exercise and structured, supervised prenatal exercise differ in their effects on maternal and neonatal outcomes ()?\n\nResearchers will compare the combined prenatal program to usual antenatal care to determine whether the intervention improves maternal and neonatal outcomes and is safe, feasible, and acceptable in a real-world clinical setting.\n\nParticipants will:\n\n1. Be screened and enrolled during pregnancy and complete baseline and follow-up assessments during pregnancy and after delivery.\n2. Be randomly assigned to either an intervention group or a usual-care control group.\n3. If assigned to the intervention group, attend supervised moderate-intensity exercise sessions three times per week (approximately 60 minutes per session) throughout pregnancy and receive antenatal perineal massage delivered by trained health professionals during late pregnancy.\n4. Provide questionnaire-based information and clinical data collected during routine visits and from medical records for outcome evaluation.",[28,29,30,31],"Postpartum Urinary Incontinence","Postpartum Depression (PPD)","Neonatal Complications","Gestational Diabetes",[33,34,35,36,37],"Exercise","Urinary Incontinence","Postpartum Depression","Macrosomia","Pregnancy","NOT_YET_RECRUITING","2025-12-17",{"date":41,"type":42},"2026-01-02","ACTUAL",{"date":44,"type":22},"2026-01-01",{"date":46,"type":22},"2029-12-31",{"name":48,"class":49},"South China Normal University","OTHER",""]