Postpartum Quality of LifeNCT07865065
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
A study testing Obstetric training in people with Postpartum Quality of Life and Peripartal Maternal Trauma, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Quality of Life, Peripartal Maternal Trauma
- What is being tested?
- Obstetric training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Provision of written informed consent
- Primiparity
- Singleton pregnancy
- Gestational age ≥ 36 + 0 weeks at the time of delivery
- Vaginal delivery, including spontaneous, forceps-assisted, or vacuum-assisted births
- No history of anorectal disease and no prior anal or rectal surgery
Who cannot join
- Multiparity
- Premature delivery
- Twin pregnancy
- Any preexisting anorectal disease
- Preexisting urinary and/or anal incontinence before pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové
Dominik Habes, MD, +420732545650, dominik.habes@seznam.cz
About this study
Official title: Effect of Structured Perineal Care Training on Postpartum Quality of Life and Sonographic Maternal Injury Detection
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.
Read more
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.
- Being tested
- Obstetric training
- Keywords
- Postpartal QoL, Obstetric anal sphincter injury, prevention, obstetric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric trainingOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline cohort | No intervention | Not described |
| Postinterventional cohort | Experimental | Not described Receives: Other: Obstetric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of anal incontinence
Can structured obstetric training decrease the incidence of postpartum anal incontinence?
Measured: Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.
Change of stress urinary incontinence
Does the intervention reduce the frequency of postpartum stress urinary incontinence?
Measured: Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.
Secondary outcomes (4)
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.
Measured: 3 months after delivery
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.
Measured: 3 months after delivery
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.
Measured: 3 months after delivery
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°.
Measured: 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865065
- Sponsor's protocol ID
- 202507P02
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Perineal Care Training on Postpartum Quality of Life and Sonographic Maternal Injury Detection
- ClinicalTrials.gov ID
- NCT07865065
- Acronym / sponsor ID
- 202507P02
- Keywords
- Postpartal QoL, Obstetric anal sphincter injury, prevention, obstetric training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline cohort | No intervention | – |
| Postinterventional cohort | Experimental | Other: Obstetric training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Provision of written informed consent
- Primiparity
- Singleton pregnancy
- Gestational age ≥ 36 + 0 weeks at the time of delivery
Key exclusion criteria (5 listed)
- Multiparity
- Premature delivery
- Twin pregnancy
- Any preexisting anorectal disease
- Preexisting urinary and/or anal incontinence before pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric trainingThe 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. | Other | Postinterventional cohort |
Primary outcome
Change of anal incontinence
Time frame: Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.
Can structured obstetric training decrease the incidence of postpartum anal incontinence?
Change of stress urinary incontinence
Time frame: Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.
Does the intervention reduce the frequency of postpartum stress urinary incontinence?
4 secondary outcomes
Levator ani avulsion assessed by ultrasound
Time frame: 3 months after delivery
Urethral mobility and urethral descent assessed by ultrasound
Time frame: 3 months after delivery
Pelvic organ prolapse parameters assessed by ultrasound
Time frame: 3 months after delivery
Anal sphincter defects assessed by ultrasound
Time frame: 3 months after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstetric training in people with Postpartum Quality of Life and Peripartal Maternal Trauma, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominik Habes, MD (+420732545650, dominik.habes@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of anal incontinence (time frame: Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.