An interventional study of Physiotherapeutic protocol and Usual maternity care in Episiotomy, Lacerations Perineal and Obstetric Anal Sphincter Injury, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
The aim of this study is to assess the effectiveness of a pelvic floor muscle training (PFMT) protocol associated with cryotherapy initiated in the immediate postpartum period in relieving pain in primiparous women who suffered perineal trauma during vaginal delivery. This is a hybrid effectiveness-implementation type 1 randomized controlled trial with economic evaluation, which will include 82 primiparous women who suffered a perineal tear of grade 2 or above or episiotomy during vaginal delivery. The study participants will be selected from among the women who gave birth at the Hospital das Clínicas in Ribeirão Preto and will be randomly assigned to participate in one of two study groups: the Control Group will receive the usual maternity care, that includes suturing the injury and analgesic medication, and the Intervention Group will receive the usual care combined with a physiotherapy protocol of PFMT and cryotherapy, starting in the immediate postpartum period and lasting 3 months. The primary outcome of the study will be the change in perineal pain intensity assessed using an 11-point Numerical Rating Scale; and the secondary outcomes will be self-reported pelvic floor dysfunction, recovery from injury, functionality, health-related quality of life, use of pain medication, genital self-image and implementation outcomes (satisfaction, acceptability, adequacy, feasibility, equity and adherence to the protocol). Assessments will be carried out by a group of health professionals, including physiotherapists and physicians, at 11 points up to 6 months after delivery. Two doctors from the service will be responsible for carrying out the transperineal ultrasound examination to assess the injury, which will be sent to a third international collaborating physician (SD) to assess the results blindly. The other assessments will be carried out by two physiotherapists.Descriptive statistics will be used, including the ANOVA test to confirm homogeneity between the groups, the chi-square test or Fisher's test for categorical variables and Student's t-test or Wilcoxon's non-parametric test for independent samples for quantitative variables.
This study is a type 1 hybrid randomised controlled clinical trial of effectiveness-implementation, with economic evaluation and blinded assessor, which aims to assess the effectiveness and cost-effectiveness of a physiotherapy protocol that combines pelvic floor muscle training (PFMT) with cryotherapy, initiated immediately after vaginal delivery in primiparas who have suffered perineal laceration grade 2 or above or episiotomy.
Eighty-two women who gave birth at the Hospital das Clínicas of the Ribeirão Preto Medical School - USP will be recruited. Participants will be randomised into two groups: Control Group, which will receive only the usual maternity care (analgesic medication and sutures); and Intervention Group, which will receive, in addition to the usual care, the physiotherapy protocol.
The physiotherapy protocol consists of one in-person session during hospitalisation, which will include 20 minutes of cryotherapy and initial instructions on pelvic floor muscle contraction (PFM). After hospital discharge, 12 weekly PFMT sessions will be conducted remotely (online), with guidance for daily continuation of home exercises and application of cryotherapy as needed for perineal pain relief.
The primary outcome will be the intensity of perineal pain, assessed using an 11-point numerical rating scale at the following times: 6-10 hours postpartum, 30 minutes after initial intervention, weekly in the first month, fortnightly in the second month, and at 3 and 6 months postpartum.
Secondary outcome measures include self-reported pelvic floor dysfunction (Australian Pelvic Floor Questionnaire and Wexner Scale), anatomical and functional recovery of the PFM (transperineal ultrasound and vaginal palpation using the modified Oxford scale), functionality (International Physical Activity Questionnaire - IPAQ and functional limitation numerical scale), health-related quality of life (EQ-5D-3L), use of analgesic medications, genital self-image (Female Genital Self-image Scale), gender-based violence (WHO-adapted questionnaire), and implementation outcomes (acceptability, adequacy, feasibility, and adherence to the protocol).
In addition, a comprehensive economic analysis will be conducted from the perspective of society, with a time horizon of 6 months, including cost-effectiveness analysis (clinical outcome: pain intensity) and cost-utility analysis (QALY). The costs evaluated will include interventions, health resources used (medications, tests, medical consultations, and additional physiotherapy sessions), complementary expenses (transportation and caregiver), and loss of productivity.
This protocol may offer a safe, non-pharmacological, effective, and potentially cost-effective intervention for the relief of perineal pain and prevention of pelvic floor dysfunction in primiparous women after vaginal delivery with perineal trauma, and may contribute significantly to public policies and clinical practices in the Brazilian Unified Health System (SUS).
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 82 is above the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants in this group will be selected from among primiparous women aged 18 or over, who have suffered a perineal laceration of grade 2 or above or episiotomy, with ≥37 weeks of gestation at the time of delivery, with no history of neurological diseases, and without perineal diseases. According to the 10-group Robson Classification System, only women belonging to group 1 and group 2a will be included. This arm will receive standard postpartum care for perineal trauma from the maternity hospital.
Other: Usual maternity care
Participants in this group will be selected from among primiparous women aged 18 or over, who have suffered a perineal laceration of grade 2 or above or episiotomy, with ≥37 weeks of gestation at the time of delivery, with no history of neurological diseases, and without perineal diseases. According to the 10-group Robson Classification System, only women belonging to group 1 and group 2a will be included. The women randomized to the Intervention Group the physiotherapeutic protocol (pelvic floor muscle training and cryotherapy, starting in the imediate postpartum and lasting 3 months).
Other: Physiotherapeutic protocol
The women randomized to the Intervention Group will receive the following interventions: During hospitalization: Pelvic Floor Muscle Contraction, observing the participant's ability to contract and advising on how to perform it, associated with cryotherapy and information on physiotherapy in women's health, pelvic floor muscles and its dysfunctions, as well as guidance on the care to be taken during hospitalization and after discharge, including guidance on postures to be adopted or avoided, breathing control, load management, intimate hygiene and the use of cryotherapy at home for pain relief. After hospitalization, up to 3 months after delivery: Pelvic Floor Muscle Training in weekly online sessions and guidance to carry out the training daily at home, with the same protocols and without supervision. A total of 12 individual online sessions.
Participants in the control group will receive standard postpartum care for perineal trauma from the maternity hospital, which includes suturing the injury and oral analgesic medication.
Change in perineal pain intensity
The change in the intensity of perineal pain will be assessed using an 11-point numerical rating scale (NRS), in which the participant will quantify her level of pain on a scale of 0 to 10, where 0 means no pain and 10 means the worst pain imaginable; a change of 2 points in the NRS will be considered clinically significant. The pain assessment will be done by asking the participants: "What is the level of pain in your intimate area at the moment?" and "Do you believe you have taken any measures that could have improved or worsened your pain today?". If the answer is yes, the participant will be asked to specify the measure she believes has worsened or relieved the pain. The assessment will be carried out in person during hospitalization, and after discharge, via text message at the end of the day (around 6pm).
Time frame: Up to 6 months postpartum
Self-reported symptoms of pelvic floor dysfunction
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.
Time frame: Up to 6 months postpartum.
Anal incontinence
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.
Time frame: Up to 3 months postpartum.
Integrity of the levator ani muscle
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.
Time frame: Up to 3 months postpartum
Microtrauma of the levator ani muscle
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.
Time frame: Up to 3 months postpartum
Obstetric anal sphincter muscle injury (OASI)
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.
Time frame: Up to 3 months postpartum
Self-perception
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.
Time frame: Up to 3 months postpartum
Function of the pelvic floor muscles
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.
Time frame: Up to 3 months postpartum
Functionality
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.
Time frame: Up to 6 months postpartum.
Level of physical activity
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.
Time frame: Up to 6 months postpartum.
Health-related quality of life
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.
Time frame: Up to 6 months postpartum.
Use of medication
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.
Time frame: Up to 6 months postpartum.
Genital self-image
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.
Time frame: Up to 3 months postpartum.
Acceptability
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.
Time frame: Up to 3 months postpartum
Appropriateness
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.
Time frame: Up to 3 months postpartum
Intervention's feasibility
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.
Time frame: Up to 3 months postpartum
Participant's satisfaction
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.
Time frame: Up to 3 months postpartum
Participant's adherence
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.
Time frame: Up to 3 months postpartum
Gender-based violence
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.
Time frame: Up to 3 months postpartum
Economic evaluation
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.
Time frame: Up to 6 months postpartum
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data (IPD) that underlie the results of this study (after de-identification) will be made available upon reasonable request. Data will include variables related to the primary and secondary outcomes, as well as the study protocol and statistical analysis plan. Requests will be evaluated on a case-by-case basis to assess the scientific merit and credibility of the proposal. Access will be granted only to qualified researchers with appropriate ethical approvals and data protection measures in place. Requests should be submitted to the principal investigator at carolinesoarespaula@gmail.com.
Started Nov 2025 (actual). Primary completion is estimated for Aug 2027, 21 months after the start.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 21 months is above that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
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