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

Официальное название

Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Postpartum Primiparas After Perineal Trauma: A Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial With Economic Evaluation

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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, br
• Другое Usual maternity care
  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.

Первичные конечные точки

• Change in perineal pain intensity [Срок оценки: Up to 6 months postpartum]

Вторичные конечные точки (12)

• Self-reported symptoms of pelvic floor dysfunction [Срок оценки: Up to 6 months postpartum.]
• Anal incontinence [Срок оценки: Up to 3 months postpartum.]
• Integrity of the levator ani muscle [Срок оценки: Up to 3 months postpartum]
• Microtrauma of the levator ani muscle [Срок оценки: Up to 3 months postpartum]
• Obstetric anal sphincter muscle injury (OASI) [Срок оценки: Up to 3 months postpartum]
• Self-perception [Срок оценки: Up to 3 months postpartum]
• Function of the pelvic floor muscles [Срок оценки: Up to 3 months postpartum]
• Functionality [Срок оценки: Up to 6 months postpartum.]
• Level of physical activity [Срок оценки: Up to 6 months postpartum.]
• Health-related quality of life [Срок оценки: Up to 6 months postpartum.]
• Use of medication [Срок оценки: Up to 6 months postpartum.]
• Genital self-image [Срок оценки: Up to 3 months postpartum.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto — Ribeirão Preto

Публикации

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• Schraiber LB, Latorre Mdo R, Franca I Jr, Segri NJ, D'Oliveira AF. Validity of the WHO VAW study instrument for estimating gender-based violence against women. Rev Saude Publica. 2010 Aug;44(4):658-66. doi: 10.1590/s0034-89102010000400009. English, Portuguese. PMID 20676557
• Fioratti I, Santos VS, Fernandes LG, Rodrigues KA, Soares RJ, Saragiotto BT. Translation, cross-cultural adaptation and measurement properties of three implementation measures into Brazilian-Portuguese. Arch Physiother. 2023 Mar 27;13(1):7. doi: 10.1186/s40945-023-00160-x. PMID 36967380
• Arruda, G. T. D., Silva, E. V. D., Somavilla, P., Oliveira, M. C. R. D., & Braz, M. M. (2023). Female Genital Self-image Scale (FGSIS): cut-off point, reliability, and validation of measurement properties in Brazilian women. Fisioterapia e Pesquisa, 30, e22015823en.
• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. PMID 22310560
• Lu YY, Su ML, Gau ML, Lin KC, Au HK. The efficacy of cold-gel packing for relieving episiotomy pain - a quasi-randomised control trial. Contemp Nurse. 2015;50(1):26-35. doi: 10.1080/10376178.2015.1010257. Epub 2015 Jun 10. PMID 26058405
• Brennen R, Frawley HC, Martin J, Haines TP. Group-based pelvic floor muscle training for all women during pregnancy is more cost-effective than postnatal training for women with urinary incontinence: cost-effectiveness analysis of a systematic review. J Physiother. 2021 Apr;67(2):105-114. doi: 10.1016/j.jphys.2021.03.001. Epub 2021 Mar 23. PMID 33771484

Идентификаторы

NCT: NCT07170007 · 10750271

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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