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

NCT07170007 | Recruiting

• 1 other identifier: 10750271
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

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

Keywords

pelvic floor dysfunction; woman's health; perineal pain; vaginal birth; perineal tear; postpartum

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 6 months postpartum

Secondary Outcomes (19)

• Self-reported symptoms of pelvic floor dysfunction

  Up to 6 months postpartum.

• Anal incontinence

  Up to 3 months postpartum.

• Integrity of the levator ani muscle

  Up to 3 months postpartum

• Microtrauma of the levator ani muscle

  Up to 3 months postpartum

• Obstetric anal sphincter muscle injury (OASI)

  Up to 3 months postpartum

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Intervention Group

EXPERIMENTAL

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

Interventions

Physiotherapeutic protocol 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.

Intervention Group

Usual maternity care 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

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Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Caroline Soares de Paula

CONTACT

+55 19 996307633; carolinesoarespaula@gmail.com

Cristine Homsi Jorge

CONTACT

+55 16 996217919; cristine@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a parallel-group, randomized controlled trial with two arms: an intervention group receiving a physiotherapeutic protocol and a control group receiving usual postpartum care. Participants will be randomly allocated, and outcome assessors will be blinded to group assignment. The study follows a Type 1 hybrid effectiveness-implementation design and includes an economic evaluation.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 12, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): March 20, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)