[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600961":3},{"organization":4,"outcomesModule":7,"designInfo":158,"detailedDescription":164,"studyPopulation":157,"armGroups":165,"interventions":178,"overallOfficials":187,"centralContacts":192,"locations":201,"responsibleParty":216,"collaborators":218,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":157,"eligibilityCriteria":233,"healthyVolunteers":234,"sex":235,"minAge":236,"maxAge":157,"enrollmentInfo":237,"targetDuration":157,"studyType":240,"phases":241,"briefSummary":243,"conditions":244,"keywords":250,"overallStatus":204,"whyStopped":157,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":157},[9],{"measure":10,"description":11,"timeFrame":12},"The presence of urinary incontinence (UI) at 3 months postpartum","International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score \\> 0.","At 3 months follow-up after giving birth",[14,18,21,24,27,30,32,36,39,42,45,48,50,52,55,58,60,63,66,69,72,75,79,82,85,89,91,94,96,99,102,104,106,109,111,114,116,118,120,124,127,131,134,137,141,145,149,152,155],{"measure":15,"description":16,"timeFrame":17},"The presence of urinary incontinence at inclusion","ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \\> 0) (binary outcome)","At baseline: inclusion",{"measure":19,"description":20,"timeFrame":17},"Urinary incontinence severity at inclusion","ICIQ-UI SF score between 0-21. Outcome is continuous",{"measure":22,"description":16,"timeFrame":23},"The presence of urinary incontinence at the 2nd trimester of pregnancy","At follow-up gestational age 26 weeks and 0 days",{"measure":25,"description":26,"timeFrame":23},"Urinary incontinence severity at the 2nd trimester of pregnancy","ICIQ-UI SF score between 0-21. Outome is continuous",{"measure":28,"description":16,"timeFrame":29},"The presence of urinary incontinence at the 3rd trimester of pregnancy","At follow-up gestational age 36 weeks and 0 days",{"measure":31,"description":20,"timeFrame":29},"Urinary incontinence severity at the 3rd trimester of pregnancy",{"measure":33,"description":34,"timeFrame":35},"The presence of urinary incontinence at 6 months postpartum","ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \\> 0) (binary","At follow-up at 6 months postpartum",{"measure":37,"description":38,"timeFrame":35},"UI severity at 6 months postpartum","IICIQ-UI SF score between 0-21. Outcome is continuous",{"measure":40,"description":41,"timeFrame":17},"The presence of anal incontinence (AI) at inclusion","Colorectal-anal distress inventory 8 (CRAD-8), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100). Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11)",{"measure":43,"description":44,"timeFrame":17},"Colorectal-anal symptoms severity at inclusion","Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity",{"measure":46,"description":47,"timeFrame":23},"The presence of anal incontinence (AI) in the 2nd trimester of pregnancy","Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11)",{"measure":49,"description":44,"timeFrame":23},"Colorectal-anal symptoms severity 2nd trimester of pregnancy",{"measure":51,"description":47,"timeFrame":29},"The presence of anal incontinence (AI) in the 3rd trimester of pregnancy",{"measure":53,"description":44,"timeFrame":54},"Colorectal-anal symptoms severity 3rd trimester of pregnancy","At follow-up at gestational age 36 weeks and 0 days",{"measure":56,"description":47,"timeFrame":57},"The presence of anal incontinence (AI) at 3 months postpartum","At follow-up 3 months postpartum",{"measure":59,"description":44,"timeFrame":57},"Colorectal-anal symptoms severity 3 months postpartum",{"measure":61,"description":47,"timeFrame":62},"The presence of anal incontinence (AI) at 6 months postpartum","At follow-up 6 months postpartum",{"measure":64,"description":44,"timeFrame":65},"Colorectal-anal symptoms severity 6 months postpartum","At the follow-up at 6 months postpartum",{"measure":67,"description":68,"timeFrame":17},"The presence of sexual dysfunction at inclusion","Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19",{"measure":70,"description":71,"timeFrame":17},"Sexual dysfunction severity at inclusion","Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous",{"measure":73,"description":68,"timeFrame":74},"The presence of sexual dysfunction at inclusion, during the 2nd trimester of pregnancy","At follow-up at gestational age 26 weeks and 0 days",{"measure":76,"description":77,"timeFrame":78},"Sexual dysfunction severity at inclusion, during the 2nd trimester of pregnancy","Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning","At follow-up gestational Age 26 weeks and 0 days",{"measure":80,"description":68,"timeFrame":81},"The presence of sexual dysfunction at inclusion, during the 3rd trimester of pregnancy","At follow-up at gestational Age 36 weeks and 0 days",{"measure":83,"description":77,"timeFrame":84},"Sexual dysfunction severity at inclusion, during the 3rd trimester of pregnancy","At follow-up gestational Age 36 weeks and 0 days",{"measure":86,"description":87,"timeFrame":88},"The presence of sexual dysfunction at 3 month postpartum","Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19. Lower scores indicate poorer sexual functioning","At the follow-up at 3 month postpartum",{"measure":90,"description":77,"timeFrame":88},"Sexual dysfunction severity at 3 month postpartum",{"measure":92,"description":87,"timeFrame":93},"The presence of sexual dysfunction at 6month postpartum","At the follow-up at 6 month postpartum",{"measure":95,"description":77,"timeFrame":93},"Sexual dysfunction severity at 6months postpartum",{"measure":97,"description":98,"timeFrame":17},"The presence of pelvic organ prolapse (POP) symptoms at inclusion","Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100). Outcome defined if POPDI-6 score \\> 0",{"measure":100,"description":101,"timeFrame":17},"Pelvic organ prolapse (POP) symptoms severity at inclusion","Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100). Outcome is continuous",{"measure":103,"description":98,"timeFrame":23},"The presence of pelvic organ prolapse (POP) symptoms, in the 2nd trimester of pregnancy",{"measure":105,"description":101,"timeFrame":23},"Pelvic organ prolapse (POP) symptoms severity, in the 2nd trimester of pregnancy",{"measure":107,"description":98,"timeFrame":108},"The presence of pelvic organ prolapse (POP) symptoms, in the 3rd trimester of pregnancy","At the follow-up at gestational age 36 weeks and 0 days",{"measure":110,"description":101,"timeFrame":108},"Pelvic organ prolapse (POP) symptoms severity, in the 3rd trimester of pregnancy",{"measure":112,"description":98,"timeFrame":113},"The presence of pelvic organ prolapse (POP) symptoms at 3 months postpartum","At the follow-up at 3 months postpartum",{"measure":115,"description":101,"timeFrame":113},"Pelvic organ prolapse (POP) symptoms severity at 3 months postpartum",{"measure":117,"description":98,"timeFrame":65},"The presence of pelvic organ prolapse (POP) symptoms at 6 months postpartum",{"measure":119,"description":101,"timeFrame":65},"Pelvic organ prolapse (POP) symptoms severity at 6 months postpartum",{"measure":121,"description":122,"timeFrame":123},"Delivery mode","Outcome is defined as categorical: vaginal, planned cesarean, emergency cesarean","The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.",{"measure":125,"description":126,"timeFrame":123},"Foetal position","Cephalic regular (occiput anterior), cephalic occiput posterior or breech. Outcome is categorical",{"measure":128,"description":129,"timeFrame":130},"Episiotomy","Yes or no. Outcome is binary","The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum",{"measure":132,"description":133,"timeFrame":123},"Perineal tear","Yes or no; if yes - tear degree (1st, 2nd, 3rd (3a, 3b, 3c), 4th). Outcome is categorical",{"measure":135,"description":136,"timeFrame":123},"Instrumental delivery","Yes or no; if yes - type (vacuum assisted or forceps). Outcome is binary",{"measure":138,"description":139,"timeFrame":140},"Fidelity of PFMT","Self-reported training frequency (0 times, 1-2 times, 3-4 times or more per week)","The questionnaire is filled every week from baseline to 6 months postpartum",{"measure":142,"description":143,"timeFrame":144},"Implementation outcomes","Collected through short interviews","At study completion",{"measure":146,"description":147,"timeFrame":148},"Proportion of participants reporting capability-, opportunity-, and motivation-related barriers and facilitators for pelvic floor muscle training.","Capability, Opportunity and Motivation (COM-B) related to pelvic floor muscle training, assessed using a study-specific COM-B Self-Evaluation Questionnaire. Participants may select one or more response options within the domains of capability, opportunity, and motivation. Participants may select one or more response options within the domains of capability, opportunity, and motivation. Responses are analysed as individual items (selected\u002Fnot selected), and no total score is calculated. Therefore, minimum and maximum values are not applicable. A higher frequency of endorsement of a specific item indicates a greater perceived barrier, need, or facilitator related to pelvic floor muscle training.","at the follow-up at gestational age 36 weeks and 0 days",{"measure":150,"description":151,"timeFrame":123},"Length of the first stage of delivery","Length in minutes (minimum 0 - no maximum)",{"measure":153,"description":154,"timeFrame":123},"Length of the passive second stage of delivery","Outcome is continuous and Length in minutes (minimum 0 - maximum 300 minutes).",{"measure":156,"description":154,"timeFrame":123},"Length of the active second stage of delivery",null,{"allocation":159,"interventionModel":160,"interventionModelDescription":157,"primaryPurpose":161,"observationalModel":157,"timePerspective":157,"maskingInfo":162},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":163,"maskingDescription":157,"whoMasked":157},"NONE","First-time pregnant women will be recruited through visitations received from family doctors in all obstetrics departments of the Southern Denmark Region. Women will be randomised into two groups: ( Pelvic Floor Muscle Training) PFMT and a control group (standard care). The women will receive an easily accessible, home-based PFMT program electronically in which they will be motivated to start and engage during pregnancy with continuity after birth. The data regarding pelvic floor disorders will be obtained at baseline, follow-ups once every trimester of pregnancy, as well as three months, and six months postpartum with further follow-up after the study. The data regarding obstetric outcomes will be collected from electronic patient records. For evaluation of implementation process, data regarding motivation and training acceptability will be obtained via questionnaire at the baseline and at follow-up together with telephonically interviews during pregnancy and postpartum.",[166,172],{"label":167,"type":168,"description":169,"interventionNames":170},"Pelvic Floor Muscle Training (PFMT)","EXPERIMENTAL","Participants receive access to the pelvic floor muscle training programme in addition to usual antenatal care. The programme is delivered through a mobile application and supporting materials is sent out.",[171],"Behavioral: PFMT",{"label":173,"type":174,"description":175,"interventionNames":176},"Standard care","PLACEBO_COMPARATOR","The control group will receive routine care - recommendation to do the training without any further instructions.",[177],"Behavioral: Standard care",[179,184],{"type":180,"name":181,"description":182,"armGroupLabels":183,"otherNames":157},"BEHAVIORAL","PFMT","A structured home-based pelvic floor muscle training programme consisting of progressive pelvic floor muscle exercises, training reminders as well as supportive information with educational materials and habit-building strategies. Participants are advised to perform pelvic floor muscle training three to five times per week during pregnancy and continue after birth.",[167],{"type":180,"name":173,"description":185,"armGroupLabels":186,"otherNames":157},"Routine antenatal care provided according to local clinical practice. This may include general information about pelvic floor muscle training but does not include access to the study programme, study application, structured training support, or study-specific reminders.",[173],[188],{"name":189,"affiliation":190,"role":191},"Greta Puriene","Hospital Sønderjylland","PRINCIPAL_INVESTIGATOR",[193,197],{"name":189,"role":194,"phone":195,"phoneExt":157,"email":196},"CONTACT","+4571638335","greta.puriene@rsyd.dk",{"name":198,"role":194,"phone":199,"phoneExt":157,"email":200},"Christina Prinds","+4565504953","cprinds@health.sdu.dk",[202],{"facility":203,"status":204,"city":205,"state":206,"zip":207,"country":208,"countryCode":209,"cosmosGeoPoint":210,"geoPoint":215,"contacts":157},"Sygehus Sønderjylland","RECRUITING","Aabenraa","Southern Denmark","6200","Denmark","DK",{"type":211,"coordinates":212},"Point",[213,214],9.41741,55.04434,{"lat":214,"lon":213},{"type":217,"investigatorFullName":157,"investigatorTitle":157,"investigatorAffiliation":157,"oldNameTitle":157,"oldOrganization":157},"SPONSOR",[219,221,223,225],{"name":220,"class":6},"Kolding Sygehus",{"name":222,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark",{"name":224,"class":6},"Odense University Hospital",{"name":190,"class":226},"UNKNOWN","100600961","pelvic-floor-muscle-training-during-pregnancy-100600961",false,"NCT07104292","Pelvic Floor Muscle Training During Pregnancy","Antenatal Pelvic Floor Muscle Training in Nulliparous Women: A Hybrid Type 1 Randomised Controlled Trial","Inclusion Criteria:\n\n* up to 12+6 weeks of gestation to receive invitation and up to 16+0 weeks of gestation to be enrolled\n* Para 0 (no previous birth or pregnancy \\> 16 weeks of gestation)\n* Understands, writes, and reads fluently in Danish or English\n* Has a smart phone or computer\u002Ftablet to reach the training program\n\nExclusion Criteria:\n\n* Severe psychiatric illness (e.g. schizophrenia, bipolar disorder, severe depression or anxiety)\n* Active substance abuse\n* Acute social crises (e.g. homelessness, ongoing domestic violence, severe financial instability, lack of social support)\n* Women with limited capacity to provide informed consent (due to cognitive impairment or language barriers)\n* Previous pregnancy of \\> 16 weeks of gestation",true,"FEMALE","18 Years",{"count":238,"type":239},804,"ESTIMATED","INTERVENTIONAL",[242],"NA","The project seeks to investigate effectiveness of PFMT during pregnancy.",[245,246,247,248,249],"Urinary Incontinence","Anal Incontinence","Pelvic Organ Prolapse","Sexual Dysfunction","Pelvic Floor Disorder",[251,252,253,254,255,256,257,258,259],"Pelvic floor muscle training","Pregnancy","Nulliparous women","urinary incontinence","Pelvic floor disorders","sexual function","obstetric outcomes","implementation","Randomised controlled trial","2026-10-07",{"date":262,"type":263},"2026-10-08","ACTUAL",{"date":265,"type":263},"2025-10-27",{"date":267,"type":239},"2028-08-01",{"name":5,"class":6},1]