[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659339":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":23,"studyPopulation":13,"armGroups":24,"interventions":35,"overallOfficials":43,"centralContacts":48,"locations":54,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":13,"enrollmentInfo":86,"targetDuration":13,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":104,"overallStatus":114,"whyStopped":13,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Region Skane","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Number of patients with OASI","A binary outcome based on ICD-10 codes O70.2C-O70.2X or O70.3, and\u002For the corresponding surgical procedure code (MBC33)","Within 24 hours of delivery",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","This study is a Swedish, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) superiority trial.","PREVENTION",{"masking":20,"maskingDescription":13,"whoMasked":21},"SINGLE",[22],"OUTCOMES_ASSESSOR","Purpose and aims The PeriPROTECT trial will determine the efficacy, safety and patient experience of BabySlide®, a novel perineal protection device used as an adjunct to standard manual perineal support during vaginal birth.\n\nPerineal trauma, particularly obstetric anal sphincter injury (OASI; third- and fourth-degree tears), is a leading cause of pelvic floor dysfunction and may substantially impair women's quality of life. Childbirth-related pelvic floor dysfunction, including urinary and anal incontinence, pelvic organ prolapse, sexual dysfunction, and chronic pelvic pain, affects up to one in five women after vaginal birth and frequently requires long-term physiotherapy or surgical treatment. Despite current preventive strategies, the incidence of OASI among nulliparous women in Sweden remains unacceptably high at 4.8% while 54% sustain a second-degree tear(3). Effective prevention of perineal trauma remains an important public health priority.\n\nThe investigational device, BabySlide® is a CE-marked, soft perineal protection device designed to complement standard manual perineal support during vaginal birth. The device is inserted between the fetal head and the perineum at crowning and is intended to redistribute pressure with the aim of reducing tissue strain and risk of severe perineal trauma.\n\nThis multicenter randomized controlled trial (RCT) will evaluate whether the investigational device in addition to standard perineal support reduces the incidence of OASI compared with standard perineal support alone. The secondary outcomes include second-degree perineal tears or worse, including episiotomy. Exploratory outcomes comprise detailed distribution of perineal tear subtypes, pelvic floor dysfunction, maternal and neonatal safety including healing complications, experiences of birthing women and healthcare professionals and health economic consequences. If proven effective, safe and acceptable, the investigational device could be rapidly implemented as an adjunct to existing perineal protection techniques without major changes to clinical practice, with the potential to reduce maternal morbidity and healthcare costs, as well as strengthening evidence-based obstetric care.\n\nSurvey of the field Current strategies to prevent perineal trauma include verbal guidance, warm compresses, manual perineal support, controlled delivery of the fetal head, and maternal birth positioning to reduce tissue tension. However, a 2024 Cochrane systematic review concluded that only warm compresses have demonstrated a protective effect against OASI (RR 0.46, 95% CI 0.27-0.79), while evidence remains insufficient to recommend any specific manual perineal support technique. The review highlighted the need for large, methodologically robust RCTs evaluating preventive interventions.\n\nTwo RCTs included in the Cochrane review have evaluated prototypes of the BabySlide® perineal protection device. In the most recent trial, which evaluated the investigational device among nulliparous women (n = 92), device use was associated with a 60% reduction in the odds of second-degree or more severe perineal tears (OR 0.40, 95% CI 0.17-0.94; NNT 4.3). Reduction in episiotomy and OASI rates were also observed. However, the trial was not powered to evaluate OASI and insufficient to support changes in clinical practice.\n\nSecond-degree perineal tears involving the perineal muscles are less well studied, but increasing evidence suggests an association with long-term consequences, including an increased risk of stress urinary incontinence (aOR 2.6, 95% CI 1.3-5.1). In Sweden, a revised ICD-10 subclassification of second-degree tears was introduced in 2020, enabling more detailed assessment of injury severity. Recent Swedish register data indicate that women with larger second-degree tears report more complications at both 8 weeks and 1 year postpartum, supporting the clinical relevance of distinguishing between tear subtypes. These findings support evaluation of whether the extent and subtype of second-degree trauma are associated with subsequent pelvic floor outcomes. This trial will be the first RCT to evaluate whether preventing specific second-degree tear subtypes translates into improved pelvic floor outcomes, thereby generating evidence to inform more individualized postpartum follow-up.\n\nThe investigational device was developed in Sweden and is a CE-marked medical device. Since 2024, it has been introduced into routine care at Helsingborg Hospital, for women considered at increased risk of perineal trauma (e.g first vaginal birth, large fetal weight, delayed second stage of delivery). Preliminary observational data indicate a reduction in OASI among nulliparous women from 4.1% in 2024 to 2.8% in 2026. Although these findings are observational and susceptible to confounding, they are consistent with the hypothesized mechanism of action and further support evaluation in a definitive RCT. The trial will also evaluate potential adverse effects, including infection and possible lateralisation of vaginal tears, which may increase the risk of levator ani muscle injury.\n\nThe trial is investigator-initiated and conducted independently within the academic healthcare setting. The manufacturer will not participate in the design, conduct, data analysis, interpretation, or reporting of the study. None of the investigators have a financial interest in the device or stands to gain financially from the study results.\n\nStudy design This study is a Swedish, multicenter, prospective, randomized, open-label, blinded endpoint (PROBE) superiority trial. The trial will be conducted at eight obstetric units across six Swedish healthcare regions and will adhere to Good Clinical Practice (ICH-GCP E6\\[R3\\]) and the Medical Device Regulation (MDR). The study is supported by the Swedish Network for National Clinical Studies in Obstetrics and Gynecology (SNAKS, www.snaks.se).\n\nStudy design according to the PICO model:\n\nPopulation: 4226 obstetric nulliparous women aged ≥ 18 years with a singleton live fetus in cephalic presentation at gestational age ≥34 weeks, planning vaginal birth at eight participating obstetric units across six Swedish regions. Obstetric nulliparity is defined as no previous vaginal birth and therefore includes women with a previous cesarean delivery.\n\nIntervention: Investigational device used in addition to standard perineal support. The device is positioned between the fetal head and the perineum and may remain in situ during vacuum-assisted delivery or episiotomy if clinically indicated.\n\nControl: Standard perineal support according to clinical practice, including verbal guidance, warm compresses, manual perineal support, controlled delivery of the fetal head, and maternal birth positioning to reduce tissue tension.\n\nOutcomes: The primary outcome is OASI. Secondary outcome is a composite of second-degree perineal tears or worse, including episiotomy. Exploratory outcomes include detailed characterization of perineal trauma or pelvic floor injury, maternal and neonatal adverse events, pelvic floor dysfunction, perineal wound healing complications, experiences of women and healthcare professionals and health economic outcomes. Prespecified subgroup analyses and several nested sub-studies will also be conducted.\n\nResearch questions\n\n1. Does the investigational device, used in addition to standard perineal support, reduce the incidence of OASI compared with standard care alone?\n2. Does the intervention reduce the incidence and severity of other perineal injuries, including second-degree tears and episiotomy?\n3. Does the intervention improve pelvic floor function during the first postpartum year compared with standard care alone?\n4. What is the rate of maternal and neonatal adverse events associated with the intervention compared with standard care alone?\n5. How do birthing women and healthcare professionals perceive the use of the investigational device during childbirth?\n6. Does the treatment effect vary across clinically relevant subgroups, including women with female genital mutilation?\n7. Is implementation of the investigational device cost-effective in routine obstetric care compared with standard obstetric care?\n\nWe hypothesize that the investigational device, when added to standard manual perineal support, will reduce the incidence of OASI and other clinically significant perineal trauma without increasing maternal or neonatal adverse events. We further hypothesize that the intervention will be associated with improved pelvic floor outcomes and patient-reported outcomes during the first postpartum year and will be cost-effective compared with standard care. Analyses of pelvic floor outcomes, specific patient subgroups, user experiences, and implementation will be considered exploratory. Safety analyses will be interpreted in the context of the trial being powered primarily for efficacy outcomes rather than uncommon adverse events.\n\nVariables and measures Outcome data will be collected from an electronic case report form (eCRF), the Swedish Pregnancy Register (SPR), The Swedish National Quality Register for Perineal Lacerations, the Swedish Patient Register, digital questionnaires, clinical examinations, and qualitative interviews. Data on delivery characteristics and perineal trauma will be transferred automatically from the electronic medical records to SPR while data on OASI will be transferred to the Swedish Perineal Lacerations Register. Before study initiation, participating sites will receive standardized training on the classification and registration of perineal lacerations to promote consistent reporting across sites. Validated multilingual instruments will be used to assess pelvic floor dysfunction, quality of life, sexual function, and childbirth experience. The primary, secondary, and exploratory outcomes, along with their data sources and assessment time points, are summarized in Table 1 and described in detail below.\n\nPrimary outcome: The primary outcome is OASI, defined as a binary outcome based on ICD-10 codes O70.2C-O70.2X or O70.3, and\u002For the corresponding surgical procedure code (MBC33). OASI will be classified by investigators blinded to treatment allocation, as described under Outcome assessment. Following delivery, the degree of perineal trauma and confounders not available in the registers will be recorded in the eCRF by independent investigators. At study completion, OASI data recorded in the eCRF will be cross-checked against the Swedish Perineal Lacerations Register and the SPR. Discrepancies will be resolved through review of the medical records by investigators independent of the initial outcome assessment.\n\nSecondary outcome: The secondary outcome is a composite of second-degree or more severe perineal trauma, defined as a binary outcome based on ICD-10 codes O70.1A-D, O70.2C-F, or O70.3 and\u002For episiotomy (procedure code TMA00). Data will be collected in the eCRF. OASI components will be cross-checked as described above, whereas second-degree tears and episiotomies, which are not registered in this register, will be verified using the SPR, and medical records.\n\nBackground, baseline variables and confounders: Maternal demographic characteristics, medical history, obstetric risk factors, and neonatal characteristics, including body mass index, chronic disease, gestational age, duration of labour, birthweight, and head circumference.\n\nExploratory outcomes include:\n\nPerineal trauma: detailed distribution of perineal tear subtypes, including first-, second-, and third-degree tear subclasses, episiotomy, isolated vaginal tears, and unilateral or bilateral levator ani muscle injury.\n\nPelvic floor dysfunction: symptoms of urinary-, anal incontinence, pelvic organ prolapse, deficient perineum, sexual dysfunction, dyspareunia, and childbirth-related quality of life at 2 and 12 months postpartum.\n\nMaternal safety outcomes: postpartum antibiotic treatment, wound infection, wound dehiscence, fistula formation, granuloma, pelvic haematoma, endometritis, and puerperal sepsis. A safety interim analysis will be performed for puerperal sepsis and surgical repair of wound dehiscence involving the perineal muscles within 42 days postpartum.\n\nNeonatal safety outcomes: skin lacerations, Apgar score, and Apgar score \\\u003C7 at 5 minutes.\n\nHealing complications: REEDA score, deficient perineum, anovaginal distance, genital hiatus, pelvic organ prolapse (POP-Q), and levator ani muscle injury, evaluated clinically and by three-dimensional pelvic floor ultrasound using the validated Levator Ani Deficiency score.\n\nPatient and healthcare professional experience: Women's childbirth experience will be assessed using the Second stage of labor Questionnaire (SOL-Q). Experiences of women, midwives, and obstetricians regarding the use of the device will be explored through semistructured qualitative interviews.\n\nHealth economic outcomes: Resource utilization, including transfer to the operating theatre, antibiotic treatment, length of postpartum hospital stay, outpatient revisits, readmissions, and secondary surgical repair, will be obtained from the SPR, Swedish Patient Register, and eCRF. Cost data will be collected from the accounting departments of the participating hospitals.\n\nFor completeness, a separate register-based follow-up study will be conducted 10 years after completion of the trial. Linkage via the unique personal identity number to the SPR, the Perineal Laceration Register and the Swedish Patient Register, will enable long-term evaluation of outcomes including mode of delivery in subsequent pregnancies, perineal trauma, fear of childbirth and treatment for pelvic floor dysfunction.\n\nMaterial: Patient selection, population and sample Study population and recruitment: At participating study sites, all obstetric nulliparous women (defined as women with no previous vaginal birth, including those with a previous cesarean section) planning a vaginal birth will be screened for eligibility and invited to participate. Nulliparous women are targeted because they have a substantially higher risk of OASI and other perineal trauma than women with previous vaginal births. The participating sites account for approximately 11,000 of the 32,300 annual births among nulliparous women in Sweden (3). Study information will be provided during routine antenatal care visits or on admission to the delivery ward by the responsible midwife or obstetrician. Additional study information will be available through the study website (www.periprotect.se), in antenatal clinic and delivery ward waiting rooms, and via social media to increase awareness and facilitate informed participation. Written study information will be available in Swedish, English, Arabic, and Somali. Oral information will be provided with the assistance of a professional interpreter when required. Ethical approval has been obtained to enroll women both before and after the onset of labor, provided adequate pain relief has been established, the woman wishes to receive information, and sufficient time is available to obtain informed consent.\n\nInclusion criteria: Women with no prior vaginal birth (including one previous cesarean section). Singleton, live fetus in cephalic presentation. Gestational age ≥34 weeks. Age ≥ 18 years. Planned vaginal birth.\n\nExclusion criteria: Cesarean section before randomization. Water birth. Participation in another clinical trial with perineal tear as primary outcome.\n\nRandomization and allocation: Participants will be randomly allocated in a 1:1 ratio to the intervention or control group using sequentially numbered, opaque, sealed envelopes based on site-specific randomization lists with 1:1 allocation, stratified by site, using randomly varying permuted block sizes of 4 and 6. The study procedures have been designed to minimize interference with routine obstetric care and the course of labour. Randomization will be performed in the delivery ward during the late second stage of labour, after full cervical dilatation. Participants will be allocated to either the intervention group, receiving the investigational device in addition to routine perineal support, or the control group, receiving routine perineal support alone. Randomization will be performed by designated study staff or the attending midwife or physician.\n\nIntervention and trial preparation: The investigational device will be applied between the fetal head and perineum in addition to standard manual perineal support. Training in device use and study procedures will be provided before trial initiation, informed by a feasibility study conducted in April 2026 involving 17 users, each performing 5-10 deliveries. Designated midwives at each site will receive advanced training as super-users and provide ongoing local support for device use, protocol adherence, and standardized classification of perineal tears.\n\nOutcome assessment: Perineal trauma will initially be assessed and classified by the midwives attending the birth and managed according to Swedish national guidelines with joint assessment by two midwives. According to clinical practice, when OASI is suspected, an obstetrician or gynecologist is called to clinically assess the injury and perform the repair in an operating theatre, whereas second-degree tears and episiotomies are normally repaired by midwives in the delivery room. In the trial, the obstetrician or gynecologist assessing and recording the OASI, the primary outcome, will not have been involved in the birth and will be blinded to treatment allocation. Blinding of participants and attending healthcare professionals is not feasible because of the nature of the intervention. Second-degree tears and episiotomies will not be assessed blindly because of their high incidence and the associated logistical constraints. Tertiary outcomes, including the 12-month clinical examination, will be assessed blinded to treatment allocation where feasible; any unblinding will be documented and accounted for in sensitivity analyses. Within the first few hours after birth, the attending healthcare professional will record intervention fidelity, satisfaction with the technique (VAS 1-10), operator professional experience, training level, and number of intervention-assisted births, antibiotic treatment, and other variables not available in national registers.\n\nFollow-up procedures:\n\nDigital questionnaires will be distributed two weeks postpartum and at two and 12 months postpartum to collect background characteristics and assess pelvic floor symptoms and health-related quality of life. All participants will be offered a standardized clinical examination, including three-dimensional (3D) pelvic floor ultrasound, at 12 (±2) months postpartum. Participants meeting the secondary outcome criteria will additionally be offered a clinical examination at two weeks (±1) postpartum to assess wound healing and early complications.\n\nNested qualitative study: A nested qualitative study will be conducted 3-6 months after intervention implementation. Approximately 20 participating women and 20 midwives and physicians will be purposely sampled to capture variation in relevant characteristics and experiences. In addition, a subgroup of women with female genital mutilation will be interviewed to explore experiences in this higher risk group. Interviews will explore perineal protection and device use, focusing on feasibility, acceptability, perceived safety, and implementation in routine maternity care.\n\nEstimated sample size and power According to data from the SPR, the incidence in 2023-24 of OASI at the study hospitals was 4.8% among primiparous women with vaginal births, including those delivering after one previous caesarean section. Based on the wide variation in OASI incidence reported in Sweden (1.5-8.8%), previous study result, and the observed unadjusted decline in OASI following clinical introduction of the device, a 40% reduction in OASI is considered a plausible and clinically important effect size. Sample size calculation to determine the minimum number of subjects for adequate study power for a dichotomous endpoint in a two-sided superiority trial with two independent samples revealed a sample size of 2113 women in each arm (α 0.05, β 0.8) to detect reduction in OASI from 4.8% to 2.9% with the assumption of 10% drop-outs, rendering 4226 women in total (https:\u002F\u002Fps-power-and-sample-size-calculation.software.informer.com) With the sample size required for the primary outcome, the study would have 80% power to detect a 10% relative reduction in the risk of the secondary outcome (RR 0.90)\n\nStatistical methods The primary analyses will follow the modified intention-to-treat (mITT) principle, including all randomized participants except those who undergo intrapartum caesarean section after randomization (2-3% after full cervical dilation), as they are not exposed to vaginal delivery or the intervention and not at risk of the primary or secondary perineal outcomes. The frequency of post-randomization caesarean section will be compared between groups to assess potential differential attrition. Sensitivity analyses will include a full intention-to-treat (ITT) analysis including all randomized participants and a per-protocol analysis estimating the effect of receiving the intended treatment.\n\nBaseline characteristics will be summarized descriptively by treatment group without formal statistical testing. Categorical variables will be presented as frequencies and percentages, and continuous variables as means with standard deviations or medians with interquartile ranges, as appropriate.\n\nThe primary binary outcome (OASI) will be compared between the intervention and standard-care groups using modified Poisson regression with a log link and robust variance estimation, providing risk ratios (RRs) with 95% confidence intervals (CIs). Both unadjusted and adjusted estimates will be presented. The adjusted model will include prespecified baseline characteristics considered to be prognostically associated with the outcome, irrespective of any observed baseline differences between the treatment groups.\n\nFor this multicentre study, potential clustering of outcomes within clinics will be accounted for by using robust standard errors clustered at clinic level. Alternatively, if the number of participating clinics and the distribution of participants across clinics permit, a generalised estimating equation model with clinic as the clustering variable and an exchangeable correlation structure will be used. Treatment effect estimates will be reported as adjusted risk ratios (aRRs) with 95% CIs. All statistical tests will be two-sided. A sensitivity analysis additionally adjusting for pre-specified baseline risk factors for OASI will be performed alongside the unadjusted primary analysis. Number needed to treat will be calculated for the primary outcome.\n\nThe secondary composite outcome of second-degree or more severe perineal trauma and\u002For episiotomy will be analysed using the same approach. Formal hypothesis testing will be performed only if the primary outcome is statistically significant; otherwise, results will be considered supportive. Episiotomy will additionally be analysed separately. To assess potential detection bias, a sample of perineal trauma classifications will undergo blinded independent re-adjudication, with inter-rater agreement reported by treatment group.\n\nPrespecified subgroup analyses will assess heterogeneity of treatment effects according to clinically relevant maternal, fetal and obstetric characteristics, including mode of delivery, birthweight, gestational length and female genital mutilation. These analyses will be hypothesis-generating and not adjusted for multiplicity. Exploratory analyses will assess associations between operator experience, intervention fidelity and outcomes.\n\nA cost-effectiveness analysis will compare healthcare costs and clinical outcomes between study groups. Cost uncertainty will be evaluated using non-parametric bootstrapping, and longer-term cost-effectiveness will be modelled using published epidemiological data.\n\nA blinded interim safety analysis will be performed after 50% of participants have been recruited, evaluating puerperal sepsis and wound dehiscence involving perineal muscles requiring surgical repair. This interim analysis serves solely as a pre-specified stopping rule and will use the mITT population with a one-sided significance level of 1%.\n\nThe responsible trial statistician is Professor Karin Källén. Detailed analytical procedures, including statistical models, covariates and exploratory analyses, will be prespecified in a Statistical Analysis Plan finalized before database lock and unblinded comparative analyses.\n\nData collection and follow up: Outcome data will be collected from an eCRF, national registers, digital questionnaires, clinical examinations, and qualitative interviews as further described in Variables and measures. All data will be handled in accordance with applicable data protection regulations, using pseudonymized study identification numbers, and results will be reported at the group level only.\n\nRecruitment feasibility: Approximately 90,000 women give birth annually in Sweden, including around 32,300 nulliparous women having a vaginal birth. The participating centres collectively manage approximately 11,000 vaginal births among nulliparous women annually, providing a sufficient recruitment base for the planned sample size. Based on previous Swedish intrapartum clinical trials, an inclusion rate of approximately 20% is anticipated (once all centers are fully operational) because recruitment must occur continuously in a 24-hour clinical setting. Assuming an additional 10% drop-out rate due to intrapartum caesarean section, water birth or withdrawal of consent, the recruitment target of 4,226 participants is expected to be achieved by the end of 2029, as detailed in timeline below.\n\nImplementation potential: The investigational device is CE marked, commercially available and readily integrated into existing perineal protection techniques without requiring additional infrastructure or major changes to clinical practice. With a negotiated unit cost of approximately SEK 250 (from SEK 590) compared with hospital costs of approximately SEK 62,700 for an OASI episode and SEK 30,000 for an uncomplicated vaginal birth in Swedish KPP data, even modest reductions in OASI rates could yield meaningful healthcare savings and contribute to more sustainable maternity care. Consequently, should the intervention prove effective and acceptable, implementation into routine obstetric care could be initiated rapidly. Two of the investigators are members of the national Perinatal-ARG and the steering committee of Bäckenbottenutbildning.se, contributing to the development of national guidelines and providing established networks to support dissemination of the study findings and facilitate their implementation into Swedish clinical practice.",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"Perineal protection device, BabySlide","EXPERIMENTAL","BabySlide® is a perineal protection device used during vaginal delivery in addition to standard manual perineal support.",[30],"Device: Perineal protection device, BabySlide",{"label":32,"type":6,"description":13,"interventionNames":33},"Standard manual perineal support",[34],"Other: Standard manual perineal support",[36,40],{"type":37,"name":26,"description":38,"armGroupLabels":39,"otherNames":13},"DEVICE","The investigational device, BabySlide® is a CE-marked, soft perineal protection device designed to complement standard manual perineal support during vaginal birth. The device is inserted between the fetal head and the perineum at crowning and is intended to redistribute pressure with the aim of reducing tissue strain and risk of severe perineal trauma.",[26],{"type":6,"name":32,"description":41,"armGroupLabels":42,"otherNames":13},"Standard manual perineal support during vaginal delivery according to routine clinical practice.",[32],[44],{"name":45,"affiliation":46,"role":47},"Bjarne Madsen Härdig, Associate Professor","Region Skane, Lund University","STUDY_CHAIR",[49],{"name":50,"role":51,"phone":52,"phoneExt":13,"email":53},"Åsa H Leijonhufvud, PhD, MD, Senior Consultant","CONTACT","+46424062227","asa.leijonhufvud@skane.se",[55],{"facility":56,"status":13,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Helsingborgs Lasarett","Helsingborg","25187","Sweden","SE",{"type":62,"coordinates":63},"Point",[64,65],12.69437,56.04673,{"lat":65,"lon":64},[68],{"name":69,"role":51,"phone":52,"phoneExt":13,"email":53},"Åsa H Leijonhufvud, PhD, MD, Senior consultant",{"type":71,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[73],{"name":74,"class":75},"Clinical Studies Sweden - Forum South","UNKNOWN","100659339","perineal-protection-device-for-reducing-perineal-trauma-during-vaginal-delivery-in-first-time-mothers-a-multicenter-randomized-controlled-trial-100659339",false,"NCT07862660","Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial","Risk Reduction of Perineal Trauma With a Perineal Protection Device, a Multicenter Randomized Controlled Trial - The PeriPROTECT Trial","PeriPROTECT","Inclusion Criteria:\n\n* Women with no prior vaginal birth (including one previous cesarean section). Singleton, live fetus in cephalic presentation. Gestational age ≥34 weeks. Age ≥ 18 years. Planned vaginal birth.\n\nExclusion Criteria:\n\n* Cesarean section before randomization. Water birth. Participation in another clinical trial with perineal tear as primary outcome.","FEMALE","18 Years",{"count":87,"type":88},4226,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in first-time mothers. The main questions it aims to answer are:\n\nDoes the use of BabySlide® reduce the risk of obstetric anal sphincter injury (OASI)? Does the use of BabySlide® reduce the risk of second-, third-, or fourth-degree perineal tears and\u002For episiotomy?\n\nResearchers will compare women randomized to receive BabySlide® in addition to standard manual perineal support with women receiving standard manual perineal support alone to determine whether the device reduces perineal trauma during vaginal delivery.\n\nParticipants will:\n\nbe randomized during the late second stage of labour to either BabySlide® plus standard manual perineal support or standard manual perineal support alone; receive the allocated perineal protection method during vaginal delivery; have perineal outcomes assessed and documented after delivery; and complete follow-up assessments and questionnaires after delivery to evaluate recovery and pelvic floor symptoms.",[94,95,96,97,98,99,100,101,102,103],"Pelvic Floor Dysfunction","Perineal Laceration","Wound Dehiscence","Anal Incontinence","Sexual Dysfunction and the Mode of Deliveries","Perineal Injury","Perineal Infection","Perineal Pain","Pelvic Organ Prolapse (POP)","Levator Ani Muscle Injury",[105,106,107,108,109,110,111,112,113],"perineal protection device","obstetric anal sphincter injury","perineal laceration","episiotomy","perineal tear","BabySlide","vaginal delivery","Childbirth","Primiparous","NOT_YET_RECRUITING","2026-10-01",{"date":117,"type":118},"2026-10-07","ACTUAL",{"date":120,"type":88},"2026-10-05",{"date":122,"type":88},"2030-12",{"name":5,"class":6},1]