Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital Hradec Kralove
About this trial
This prospective interventional before and after study evaluates whether structured obstetric training-covering perineal protection, improved episiotomy technique, systematic detection of obstetric anal sphincter injuries (OASI), and hands on OASI repair-can improve early postpartum quality of life and reduce peripartal pelvic floor trauma in primiparous women after term vaginal delivery.
The primary aim is to determine whether the intervention decreases the incidence of postpartum anal incontinence and stress urinary incontinence. Secondary objectives include assessing changes in ultrasound based markers of pelvic floor integrity, specifically levator ani avulsion, urethral mobility or descent, pelvic organ prolapse parameters, and anal sphincter defects.
The study population consists exclusively of primiparous women following their first term vaginal birth, minimizing confounding from prior obstetric history.
Before the training intervention, a baseline cohort was enrolled under standard obstetric practice. After all obstetric staff (physicians and midwives) completed the structured hands on training program, a post intervention cohort was enrolled, with care provided using the newly implemented techniques.
All participants undergo standardized assessment three months postpartum, including quality of life questionnaires focused on pelvic floor symptoms and transperineal ultrasound examination according to the method described by Dietz, evaluating levator ani integrity, urethral mobility, and pelvic organ support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Provision of written informed consent
Primiparity
Singleton pregnancy
Disqualifiers
Multiparity
Premature delivery
Twin pregnancy
Any preexisting anorectal disease
Trial design
Design model
Sequential
Treatments tested in this trial
Obstetric training
Other interventionThe intervention consists of staff education (physicians and midwives) in the form of obstetric training focused on perineal protection, episiotomy techniques, and the management of birth-related perineal trauma. The patients themselves do not undergo any intervention.
Treatment groups
380 Participants
are divided into 2 treatment groupsGroup A: Baseline cohortNo intervention 0 interventions
Group B: Postinterventional cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change of anal incontinence
Can structured obstetric training decrease the incidence of postpartum anal incontinence?
Time frame
Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.2
Change of stress urinary incontinence
Does the intervention reduce the frequency of postpartum stress urinary incontinence?
Time frame
Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.Secondary outcomes
1
Levator ani avulsion assessed by ultrasound
Levator ani avulsion will be assessed using 4D transperineal ultrasound (TPUS). The levator-urethra gap (LUG) will be measured according to the established ultrasound protocol. A LUG \>25 mm will be considered pathological and indicative of levator ani avulsion.
Time frame
3 months after delivery2
Urethral mobility and urethral descent assessed by ultrasound
Urethral mobility and descent will be assessed using 2D transperineal ultrasound at rest and during maximal Valsalva manoeuvre. Urethral mobility will be assessed based on the change in the angle of the mid-urethral axis between rest and maximal Valsalva. A change of \>30° will be considered indicative of urethral hypermobility, representing a recognised risk factor for stress urinary incontinence. Urethral descent will be quantified by measuring the position of the urethrovesical junction (UVJ) at rest and during maximal Valsalva. The vertical displacement of the UVJ will be measured in millimetres relative to a horizontal reference line passing through the inferior margin of the symphysis pubis.
Time frame
3 months after delivery3
Pelvic organ prolapse parameters assessed by ultrasound
Pelvic organ prolapse will be assessed using 2D transperineal ultrasound at rest and during maximal Valsalva manoeuvre. The primary points of interest will be the most distal point of the anterior vaginal wall and the cervix. Their positions will be measured in millimetres relative to a horizontal reference line passing through the inferior margin of the symphysis pubis. The change in position between rest and maximal Valsalva will be calculated.
Time frame
3 months after delivery4
Anal sphincter defects assessed by ultrasound
Anal sphincter integrity will be assessed using 4D transperineal ultrasound with tomographic ultrasound imaging (TUI). Nine tomographic slices, each separated by 2.5 mm, will be obtained according to the protocol described by Dietz. Defects of the external anal sphincter, internal anal sphincter, or both will be considered present only when the defect is visible in at least three consecutive slices and has a circumferential extent of at least 30°.
Time frame
3 months after deliverySponsors and contacts
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Source ClinicalTrials.gov