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

NCT ID: NCT07170007

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-11
• Study Completion Date: 2029-03-20

Brief Summary

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.

Detailed Description

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).

Conditions

Episiotomy; Lacerations Perineal; Obstetric Anal Sphincter Injury; Perineal Injury; Perineal Laceration, Tear, or Rupture During Delivery; Perineal Pain; Perineal Tear Resulting From Childbirth; Perineal Tear and Episiotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Usual maternity care

Intervention Type: OTHER

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.

Intervention Group

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).

Group Type: EXPERIMENTAL

Physiotherapeutic protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Caroline Soares de Paula

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Caroline Soares de Paula

Role: CONTACT

carolinesoarespaula@gmail.com

+55 19 996307633

Cristine Homsi Jorge

Role: CONTACT

cristine@fmrp.usp.br

+55 16 996217919

Facility Contacts

Cristine Homsi Jorge

Role: primary

cristine@fmrp.usp.br

+55 16 996217919

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Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

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Related Links

https://www.ibge.gov.br/

Related Info

http://sigtap.datasus.gov.br/tabela-unificada/app/sec/inicio.jsp

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Other Identifiers

10750271

Identifier Type: -

Identifier Source: org_study_id