Perineal Tear Resulting From Childbirth
Conditions
Keywords
Perineum. Perineorraphy. Pelvic floor exercise.
Brief summary
The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.
Detailed description
A randomized controlled trial which aims to evaluate objective and subjective outcomes following perineorraphy compared with pelvic floor exercise after vaginal delivery. 70 women seeking help for improperly healed perineal tear following vaginal delivery, matching our inclusion- and exclusion criteria, will be randomised into two different treatment groups, 35 to operative treatment, perineorraphy, and 35 to conservative treatment, tutored pelvic floor exercise. Assessment pre-and 6 months postoperatively will include clinical evaluation and condition specific validated questionnaires. Surgical characteristics and adverse events during follow-up are also registered.
Interventions
PROCEDUREPerineorraphy
Surgery for improperly healed perineal tear
Pelvic floor exercise tutored by physio therapist.
Sponsors
Stockholm South General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor * height of perineum 2 cm or less. * A least 6 months post partum * stopped exclusive breastfeeding * no indication for other gynecological surgical procedure
Exclusion criteria
* history of 4th degree laceration * connective tissue disorder (Systemic lupus erythematosus, Sjögrens syndrome, Polymyalgia rheumatica, Marfans syndrome, Ehlers-Danlos syndrome) * current use of systemic corticosteroids * diabetes mellitus * suspect occult sphincter tear on ultrasound * history of previous urogynecological operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-1) | 6 months after intervention (operation or start of pelvic floor training) | Patients own assessment of improvement 6 months after intervention using a seven grade assessment tool called PGI-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound of perineum | 6 months after intervention (operation or start of pelvic floor training) | Height and depth of perineum i millimeters using ultrasonography |
| Pelvic floor distress inventory (PFDI 20) | 6 months after intervention (operation or start of pelvic floor training) | 20 validated questions concerning prolapse related symptoms |
| Pelvic Floor Impact Questionnaire (PIFQ-7) | 6 months after intervention (operation or start of pelvic floor training) | Evaluates the effect on quality of lafe. |
| POP-Q (Pelvic organ Quantification System) | 6 months after intervention (operation or start of pelvic floor training) | Pelvic organ prolapse is graded via the Pelvic organ Quantification System (POP-Q) into stage 0-4. It is a validated way to clinically assess and stage of the female pelvic floor. |
| Hospital Anxiety and Depression Scale (HAD) | 6 months after intervention (operation or start of pelvic floor training) | Evaluate psychological effects |
| Vaginal symptoms | 6 months after intervention (operation or start of pelvic floor training) | Three non-validated questions concerning vaginal symptoms; sensation of wideness, vaginal flatulence and excessive discharge. |
| Surgical complications | From surgery up to 6 months postoperatively | Infections.Bleedings. Other complications. |
| Prolapse Incontinence Sexual Questionnaire (PISQ) | 6 months after intervention (operation or start of pelvic floor training) | Evaluate effects on sexual functions |
Countries
Sweden
Outcome results
None listed