Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma

Australian Pelvic Floor Questionnaire, comprising 42 questions in four domains: bladder, bowel, sexual function, and pelvic organ prolapse. The higher the score, the worse the function assessed.

The bladder section consists of 15 questions, resulting in a final score of 0-45. The bowel section consists of 12 questions, resulting in a final score of 0-34, and the prolapse section consists of 5 questions, resulting in a final score of 0-15, and the sexual function section consists of 10 questions, two qualitative and eight quantitative, with variable scores and a final score of 0-21. A change of 1 point in each section of the scale will be considered clinically significant.

This assessment will be carried out at four points in time: At baseline; 6-8 weeks after delivery; 3 and 6 months after delivery, remotely.

The Wexner Scale will be used to assess anal incontinence. The final score ranges from 0 to 20, and the higher the value, the greater the degree of incontinence of the participant. The Wexner scale will be assessed at two points in time: At baseline, and 3 months after delivery.

The integrity of the the levator ani muscle will be assessed using four-dimensional transperineal ultrasound (TPUS). This evaluation is performed offline reconstructing an axial view of the pelvis from the beforementioned ultrasound volume. A tomographic view is used, and the levator ani muscle (LAM) is defined as injured if there is a discontinuity between the LAM and the pubic bone in the plane of minimal hiatal dimension and the 2 slices cranially with 2.5 mm slice intervals. This is evaluated during maximum pelvic floor contraction, or at rest if contraction is not possible. The LAM will be classified as normal, unilateral avulsion, bilateral avulsion. This exam will be performed twice; shortly after birth and 3 months post partum.

The integrity of the the levator ani muscle will be assessed using four-dimensional transperineal ultrasound (TPUS). Microtrauma is defined as permanent injury to the muscle fibers without overt avulsion. It is diagnosed during maximum strain (Valsalva maneuver) where a 3D reconstruction of the levator ani muscle (LAM) allows for measuring the levator hiatus (the opening between the puborectalis muscle posterolaterally and the symphysis pubis anteriorly). An area of > 25cm2 is used as a cut off. The results will be presented as total area of the levator hiatus during contraction, relaxation and Valsalva manuever (cm2); anteroposterior diameter of the levator hiatus during contraction, relaxation and Valsalva manuever (mm); transverse diameter of the levator hiatus during contraction, relaxation and Valsalva manuever (mm) This exam will be performed twice; shortly after birth and 3 months post partum.

The integrity of the the levator ani muscle will be assessed using four-dimensional transperineal ultrasound (TPUS). The examination intends to evaluate the sphincter apparatus to assess signs of scarring indicating an OASI that has been adequately repaired and of muscle defects indicating either an occult OASI, not identified primarily, or a suboptimal healing.

These measures are evaluated through the same sonographic method as described above, though an axial plane where 6 slices of equal intervals will be examined. Diagnosis of a persistent sphincter defect is the loss of continuity of the circular internal and/or external sphincter of more than 30 degrees.

Each slice will be recorded as normal, scar or defect; whenever a defect (>30 degrees) are identified, the size (degrees) are recorded for each of the six slices.

The presence of a defect in 4 or more of the six slices is defined as an occult OASI. It will be performed shortly after birth and 3 months post partum.

The self-perception assessment will be carried out using the 'Questionnaire on knowledge and perception of the female pelvic floor', consisting of three parts, which assess the participant's knowledge of the anatomy and function of the pelvic floor muscles, symptoms and treatments for pelvic floor muscle dysfunction, and perception. Each statement has a score ranging from 0 to 3, depending on the statement, generating a maximum score of 40 points. The higher the score obtained, the greater the level of knowledge and perception of contraction and relaxation of the pelvic floor muscles. This assessment will be carried out at baseline and 3 months after delivery.

The assessment of pelvic floor muscle function will also be performed using the Modified Oxford Scale through vaginal palpation. This scale grades pelvic floor muscle function on a scale of 5 degrees, with degree 0: absence of muscle contraction, degree 1: slight muscle contraction; degree 2: weak contraction; degree 3: moderate contraction; degree 4: good contraction; degree 5: strong contraction. Vaginal palpation will be performed with participants in a supine position with knees and hips flexed and abducted and feet resting on the stretcher. Participants will be asked to perform maximum voluntary contraction of the pelvic floor muscles. Participants will be instructed to perform 3 contractions, and the evaluator will rate the last contraction. The higher the score obtained, the better the function of the pelvic floor muscles. This assessment will be carried out after the end of treatment (3 months postpartum), in person.

Functionality will be assessed by estimating the limitations and restrictions of the parturient in performing activities during hospitalisation and after discharge of participants due to perineal trauma, using a numerical rating scale where 0 represents no difficulty and 10 represents inability to perform the activity; the higher the score, the worse the functionality. The activities questioned will be: turning over in bed, picking up the baby (lying in bed, sitting in bed, standing), breastfeeding (lying down, sitting on the bed, standing), changing the baby, sitting on the bed, getting out of bed, walking, sitting on the toilet, urinating, defecating, performing intimate hygiene after urinating or defecating, getting up from the toilet, and bathing.

Functionality will be assessed at baseline; 6-8 weeks after delivery; 3 and 6 months after delivery.

The level of physical activity will be assessed using the International Physical Activity Questionnaire - Short Version, which consists of three questions about daily physical activity, in order to determine the frequency and duration of the activity. The first question relates to strenuous activities (running, playing football, heavy housework), the second to moderate activities (swimming, dancing, gardening). The third question asks how often and for how long the person takes a continuous 10-minute walk.

Through this questionnaire, participants will be classified as sedentary, insufficiently active, active, or very active.

This assessment will be carried out at baseline; 6-8 weeks after delivery; 3 and 6 months after delivery.

Health-related quality of life will be assessed using the EQ-5D-3L instrument, which comprises two parts: a descriptive system and a visual analog scale. The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where health states are classified with a five-digit number representing the level of severity in each dimension, making it possible to identify 243 health states. The health states identified will be converted into utility using the Brazilian tariff. Utility ranges from -0.2 to 1, with -0.2 representing the worst state of health and 1 representing the best state of health. The visual analog scale ranges from 0 to 100, where participants will self-report their state of health. This assessment will be carried out at baseline; 6-8 weeks after delivery; 3 and 6 months after delivery.

Medication use will be monitored in a way that all participants will be asked to record the type and dose of medication used, the duration of intervals and pain before and after administration in a self-reported medication diary that will be provided to participants at baseline, and the blinded evaluator will collect this information via phone calls at the following times: 6-8 weeks after randomization; 3 months after delivery; and 6 months after delivery.

The participants' genital self-image will be assessed using the female genital self-image scale, resulting in a final score that ranges from 7 to 28 points. A score higher than 22 classifies women as satisfied with their genital self-image.

Genital self-image will be assessed at baseline and 3 months after delivery.

Acceptability will be assessed using the Intervention Acceptability Measure, which consists of four questions scored from 1 to 5, where 1 means 'strongly disagree' and 5 means 'strongly agree,' resulting in a final score of 4 to 20 points. The higher the score, the better the acceptability. Acceptability will only be assessed 3 months after delivery, or after the last session in the event of dropouts.

Appropriateness will be assessed using the Intervention Appropriateness Measure, which consists of four questions scored from 1 to 5, where 1 means 'strongly disagree' and 5 means 'strongly agree,' resulting in a final score of 4 to 20 points. The higher the score, the better the appropriateness. Appropriateness will only be assessed 3 months after delivery, or after the last session in the event of dropouts.

Feasibility will be assessed using the Intervention Feasibility Measure, which consists of four questions scored from 1 to 5, where 1 means 'strongly disagree' and 5 means 'strongly agree,' resulting in a final score of 4 to 20 points. The higher the score, the better the feasibility. Feasibility will only be assessed 3 months after delivery, or after the last session in the event of dropouts.

The participant's satisfaction with the protocol and its outcome will be assessed using a numerical rating scale scored from 0 to 3, where 0 represents complete dissatisfaction, 1 represents moderate dissatisfaction, 2 represents moderate satisfaction, and 3 represents complete satisfaction, resulting in a final score of 0-15. The higher the score obtained, the greater the satisfaction. Satisfaction will only be assessed 3 months after delivery, or after the last session in the event of dropouts.

The participant's adherence to treatment will be assessed using a questionnaire with questions about the continuous use of resources, participation in online sessions, and the practice of pelvic floor muscle training at home, whether there are any modifications that the participant believes are necessary to the protocol, as well as the retention and dropout rates of participants. In cases of withdrawal, a question about the reason for withdrawal will be added. Adherence will only be assessed 3 months after delivery, or after the last session in the event of dropouts.

Gender-based violence will be assessed using the "Adapted Questionnaire: Multi-Country Study on Women's Health and Domestic Violence (WHO)", composed of 14 questions covering psychological, physical and sexual violence. The assessment of violence will be carried out at baseline and 3 months after delivery, where the latter will include the question "Were you forced to have sexual intercourse before the end of the 40-day protection period?" If the answer is positive, it will be considered sexual violence.

The economic evaluation will be carried out from society's perspective. The costs to society will be made up of the costs of the interventions, health care costs (use of resources consumed by the women), patient/family costs (complementary expenses, informal care and transport costs) and lost productivity (estimated from the hours of absenteeism from work, paid and unpaid, of the woman and her companion), and will be identified by a self-reported cost diary, collected 6 to 8 weeks after randomization, 3 and 6 months after delivery.