Low Power Laser for Spontaneous Perineal Laceration

NCT04914182 | Suspended

• 1 other identifier: LASER
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Scenario: spontaneous perineal laceration is an injury to the tissue in the perineum region, which can occur during vaginal delivery. The lesion can be classified into four degrees, according to the structures affected, with degrees one and two being more common. Some consequences may arise due to lacerations, such as perineal pain, genito-pelvic pain, in addition to infection, and dehiscence of the lesion, which may last up to one year after delivery. A laser is a form of non-ionizing radiation and when used in the repair process it is capable of generating analgesic, anti-inflammatory, and healing effects. Low-level laser treatment has been used in several areas, promoting cellular and vascular responses capable of accelerating the repair of injured tissue, in addition to pain relief and consequently capable of improving patients' quality of life. Objective: To determine the effects of low-power laser on the acceleration of the healing process and pain relief in primiparous women who had a spontaneous perineal tear, grade one and two, during normal delivery. Methods: a pilot randomized clinical trial will be carried out. Two groups will be divided randomly, one group will receive the application of the laser, and the second group the laser "sham". Data collection will be carried out at the LAbor and delivery rooms of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP). Primiparous women who had a spontaneous perineal tear, grades one and two, over 18 years of age or younger who are in charge, with a full-term pregnancy, single fetus, cephalic presentation, and who have been admitted to labor at the ANC will be included, excluding patients who are transferred to another sector, those that evolve to a cesarean section or need episiotomy or curettage and, in addition, the presence of infection during childbirth assistance, postpartum hemorrhage and suspected or diagnosed COVID-19. The laser will be applied at three predetermined moments: six hours, 24, and 48 hours after delivery. To evaluate the healing process a REEDA scale and a Peri-rule will be used. The assessment of pain intensity will be through the Visual Analogue Scale (VAS). Ethical Aspects: the research will be submitted to the IMIP Research Ethics Committee and data collection will begin after its approval. All data will be kept confidential and confidential, the participant will be asked to sign the Informed Consent Form before beginning any procedure.

Conditions

Perineal Tear

Keywords

perineal; laser; pain; Visual Analog Scale

Outcome Measures

Primary Outcomes (5)

• SIZE OF LACERATION 6 hours after delivery

  Size in centimeters of the perineal laceration, measured by the PERI-RULE 6 hours after delivery

  6 HOURS

• SIZE OF LACERATION 6 hours after delivery

  Size in centimeters of the perineal laceration, measured by the PERI-RULE 24 hours after delivery

  24 hours after delivery

• SIZE OF LACERATION 6 hours after delivery

  Size in centimeters of the perineal laceration, measured by the PERI-RULE 48 hours after delivery

  48 hours after delivery

• SIZE OF LACERATION AFTER ONE WEEK

  Size in centimeters of the perineal laceration, measured by the PERI-RULE one week after delivery

  1 WEEK

• SIZE OF LACERATION AFTER 42 DAYS

  Size in centimeters of the perineal laceration, measured by the PERI-RULE after 42 days of delivery

  42 DAYS

Secondary Outcomes (35)

• REDNESS AFTER 5 HOURS

  6 hours after delivery

• REDNESS AFTER 24 HOURS

  24 hours after delivery

• REDNESS AFTER 48 HOURS

  48 hours after delivery

• REDNESS AFTER 7 DAYS

  7 days

• REDNESS AFTER 42 DAYS

  42 days

Study Arms (2)

LASER

EXPERIMENTAL

In the intervention group, the laser will be applied to the points of the edges of the lesion, with a distance of one centimeter between them. The laser will be applied in a punctual way, in points on the edges of the lesion site, with a distance of one centimeter between them. This application will take place three times: six hours after delivery, 24 and 48 hours after delivery.

Radiation: LASER

CONTROL

SHAM COMPARATOR

In the control group, the sham laser will be applied the exact same way as the real laser, to the points of the edges of the lesion, with a distance of one centimeter between them. The sham laser will be applied in a punctual way, in points on the edges of the lesion site, with a distance of one centimeter between them. This application will take place three times: six hours after delivery, 24 and 48 hours after delivery.

Radiation: CONTROL

Interventions

LASER RADIATION

Laser will be applied in specific points for perineal lacerations.

LASER

CONTROL RADIATION

A control group of sham laser will create for the patients the impression that laser is being played, with the lights of the instrument of "on mode" turned on, without biological effects.

CONTROL

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Deliveries Assisted at the labor and delivery rooms (low risk)
• Spontaneous perineal laceration (grades 1 and 2)
• Primipara
• Full-term pregnancy (37 to 41 weeks and six days)
• Women over the age of 18 or under who are the presence of a responsible party
• cephalic presentation
• Single fetus
• Admitted in labor

You may not qualify if:

• Transfer to another sector;
• Performing an episiotomy;
• Evolution to cesarean section;
• Need for curettage;
• Instrumental delivery (use of forceps and vacuum);
• A patient who had the child referred to another sector;
• Shoulder dystocia;
• Change in skin sensitivity;
• Presence of infection during childbirth care;
• Postpartum hemorrhage;
• Suspected or diagnosed with COVID-19

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

Maternidade Professor Barros Lima

Recife, Pernambuco, 52070-660, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Melania M Amorim, PhD

  IMIP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Control sham: To the patients in the control group a sham control will be applied, corresponding to the device only connected, emitting the signal of being "turned on" but without therapeutic effect. The irradiation time and the number of application points will be the same as for the intervention group. The patient will remain masked, and the investigators that will perform the statistical analysis will be masked until the end of the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the Obstetrical ICU

Model Details: A randomized clinical trial will be conducted, participants will be assigned to the intervention group or the control group in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 4, 2021
• Study Start: June 3, 2021
• Primary Completion: February 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)