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.
The study will include female at birth aged 18 years or older, primiparous (no previous pregnancy after 16 weeks), who have suffered a perineal laceration of grade ≥2 or episiotomy, with ≥37 weeks of gestation at the time of delivery, who have not used testosterone in the last 6 months, with preserved cognitive ability, no history of neurological diseases, no symptoms of vaginal or urinary tract infection and no perineal diseases such as fistulas, genital mutilation, previous perineal surgery for pelvic floor dysfunction or Crohn's disease. According to the Robson 10-Group Classification System, only women belonging to group 1 (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation in spontaneous labor) and group 2a (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation who had labor induced) will be included in the study.
Women with conditions such as severe pre-eclampsia or infections, sick newborns or women who refuse to take part in the study will not be included. Participation is voluntary and participants can withdraw from the study at any time.
Parallel
Physiotherapeutic protocol
Other interventionThe 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.
Usual maternity care
Other interventionParticipants 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).
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
