Perineal TearLASERNCT04914182
Low Power Laser for Spontaneous Perineal Laceration
A study testing LASER in people with Perineal Tear, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perineal Tear
- What is being tested?
- LASER
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jun 2021to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Shoulder dystocia;
- Change in skin sensitivity;
- Presence of infection during childbirth care;
- Postpartum hemorrhage;
- Suspected or diagnosed with COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Low Power Laser in the Cicatricial Process and Pain Relief in Primiparous People With Spontaneous Perineal Laceration After Normal Delivery
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.
Read the detailed description
In primiparous women with spontaneous perineal laceration, grade 1 and 2, during normal delivery submitted to the application of low power laser versus "sham" laser:
- Describe the biological characteristics (age, weight, height, BMI), sociodemographic (marital status, race, years studied, family income, social occupational);
- Describe the characteristics related to life habits (smoking, activity physical, pelvic physiotherapy during pregnancy, Pilates during pregnancy, yoga during pregnancy);
- Describe the previous gynecological and obstetric characteristics (number of pregnancies, type of previous births, number of abortions, suture in childbirth current) and obstetric (prenatal consultations, number of prenatal consultations, gestational age, gestational weight gain, use of oxytocin, use of analgesia, blood flow guidance, position during the second period of childbirth, hours labor, instrumental delivery, birth weight, head circumference of the newborn, shoulder dystocia, perineal laceration, the severity of lacerations, laceration extension, postpartum perineal pain);
- Compare the parameters of REEDA, such as redness, edema, bruising, secretion and approximation of the edges at each intervention and in the range of seven and 42 days after laser application;
- Compare the frequency of perineal pain and genito-pelvic pain at each intervention and between seven and 42 days after laser application;
- Compare the measurement of the extent of perineal laceration, using Peri-Rule, the each intervention and in the interval of seven and 42 days after the application of the laser.
Initially, the study will be carried out with 30 women (pilot study) for later the sample calculation will be carried out. A pilot study will be carried out, as, during the search in the database, no studies were found that address the use of low-level laser in spontaneous perineal lacerations, so that sample calculation was carried out.
Randomization for the intervention and control groups will be performed according to a list of random numbers drawn up for that purpose by an employee who does not was involved with data collection, to ensure confidentiality in the allocation. From this list, sealed and opaque envelopes will be prepared, numbered sequentially, with each number, according to the randomization table, corresponds to the patient's allocation to the intervention or control group.
For statistical analysis of the data, the domain statistical program will be used public Epi-info version 7, or higher versions. Tables will be distributed frequency distribution for categorical variables, calculating the mean and deviation standard of quantitative variables. Then, contingency tables will be used to determine the association of the independent variable (laser application) with the independent variables (REEDA scale, perineal pain, genito-pelvic pain). For determination of the strength of association will be calculated as a measure of the risk (RR) and its 95% confidence interval. All p values will be two-tailed and in all stages of the analysis will be considered a level of significance 5%.
- Conditions
- Perineal Tear
- Being tested
- LASER, CONTROL
- Keywords
- perineal, laser, pain, Visual Analog Scale
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASERRadiation
Laser will be applied in specific points for perineal lacerations.
CONTROLRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIZE OF LACERATION 6 hours after delivery
Size in centimeters of the perineal laceration, measured by the PERI-RULE 6 hours after delivery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 42 DAYS
Secondary outcomes (35)
REDNESS AFTER 5 HOURS
Redness evaluated with the REEDA (Redness, Oedema, Ecchymosis, Discharge, Approximation) scale with 6 hours after delivery The REEDA scale is a tool that assesses the inflammatory process and tissue healing in the perineal trauma, through the evaluation of five items of healing: redness (hyperaemia), oedema, ecchymosis, discharge and approximation of the wound edges (coaptation). For each assessed item, a score ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 6 hours after delivery
REDNESS AFTER 24 HOURS
Redness evaluated with the REEDA scale with 24 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 24 hours after delivery
REDNESS AFTER 48 HOURS
Redness evaluated with the REEDA scale with 48 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 48 hours after delivery
REDNESS AFTER 7 DAYS
Redness evaluated with the REEDA scale with 7 DAYS of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 7 days
REDNESS AFTER 42 DAYS
Redness evaluated with the REEDA scale with42 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 42 days
EDEMA AFTER 6 HOURS
EDEMA evaluated with the REEDA scale with 6 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 6 hours after delivery
EDEMA AFTER 24 HOURS
EDEMA evaluated with the REEDA scale with 24 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 24 hours after delivery
EDEMA AFTER 48 HOURS
EDEMA evaluated with the REEDA scale with 48 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 48 hours after delivery
EDEMA AFTER 7 DAYS
EDEMA evaluated with the REEDA scale with 7 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 7 days
EDEMA AFTER 42 DAYS
EDEMA evaluated with the REEDA scale with 42 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 42 days
BRUISING AFTER 6 HOURS
BRUISING evaluated with the REEDA scale with 6 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 6 hours after delivery
BRUISING FATER 24 HOURS
BRUISING evaluated with the REEDA scale with 24 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 24 hours after delivery
BRUISING AFTER 48 HOURS
BRUISING evaluated with the REEDA scale with 48 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 48 hours after delivery
BRUISING AFTER 7 DAYS
BRUISING evaluated with the REEDA scale with 7 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 7 days
BRUISING AFTER 42 DAYS
BRUISING evaluated with the REEDA scale with 42 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 42 days
PRESENCE OF SECRETION AFTER 6 HOURS
PRESENCE OF SECRETION evaluated with the REEDA scale with 6 hours after delivery.
ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 6 hours after delivery
PRESENCE OF SECRETION AFTER 24 HOURS
PRESENCE OF SECRETION evaluated with the REEDA scale with 24 hours after delivery.
ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 24 hours after delivery
PRESENCE OF SECRETION AFTER 48 HOURS
PRESENCE OF SECRETION evaluated with the REEDA scale with 48 hours after delivery.
ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 48 hours after delivery
PRESENCE OF SECRETION AFTER 7 DAYS
PRESENCE OF SECRETION evaluated with the REEDA scale with 7 days of delivery
Measured: 7 days
PRESENCE OF SECRETION AFTER 42 DAYS
PRESENCE OF SECRETION evaluated with the REEDA scale with 42 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 42 days
WOUND CLOSURE AFTER 6 HOURS
WOUND CLOSURE evaluated with the REEDA scale 6 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 6 hours after delivery
WOUND CLOSURE AFTER 24 HOURS
WOUND CLOSURE evaluated with the REEDA scale 24 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 24 hours after delivery
WOUND CLOSURE AFTER 48 HOURS
WOUND CLOSURE evaluated with the REEDA scale 48 hours after delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 48 hours after delivery
WOUND CLOSURE AFTER 7 DAYS
WOUND CLOSURE evaluated with the REEDA scale with 7 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 7 days
WOUND CLOSURE AFTER 42 DAYS
WOUND CLOSURE evaluated with the REEDA scale with 42 days of delivery. ranging from 0 to 3 can be assigned by the healthcare provider. A higher score indicates a greater level of tissue trauma.
Measured: 42 days
PERINEAL PAIN AFTER 6 HOURS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 6 hours of delivery (For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Measured: 6 hours of delivery
PERINEAL PAIN AFTER 24 HOURS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 24 hours of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 24 hours of delivery
PERINEAL PAIN AFTER 48 HOURS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 48 hours of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 48 hours of delivery
PERINEAL PAIN AFTER 7 DAYS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 7 days of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 7 days of delivery
PERINEAL PAIN AFTER 42 DAYS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 42 days of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 42 days of delivery
PELVIC PAIN AFTER 6 HOURS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 6 hours of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 6 hours of delivery
PELVIC PAIN AFTER 24 HOURS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 24 hours of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 24 hours of delivery
PELVIC PAIN AFTER 48 HOURS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 48 hours of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 48 hours of delivery
PELVIC PAIN AFTER 7 DAYS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 7 days of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 7 days of delivery
PELVIC PAIN AFTER 42 DAYS
PERINEAL PAIN evaluated with the Pain Visual Analog scale with 42 days of delivery For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]
Measured: 42 days of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start3 Jun 2021
- Primary completionFeb 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Because of the Pandemic, the recruitment was very slow. We stopped the study and will continue as soon as the Recruiting Centre reopens the LDR.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Melania M Amorim, PhD, Study director, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914182
- Sponsor's protocol ID
- LASER
- Acronym
- LASER
- Status last verified
- May 2023
- First submitted
- 30 May 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low Power Laser in the Cicatricial Process and Pain Relief in Primiparous People With Spontaneous Perineal Laceration After Normal Delivery
- ClinicalTrials.gov ID
- NCT04914182
- Acronym / sponsor ID
- LASER / LASER
- Conditions
- Perineal Tear
- Keywords
- perineal, laser, pain, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because of the Pandemic, the recruitment was very slow. We stopped the study and will continue as soon as the Recruiting Centre reopens the LDR.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In primiparous women with spontaneous perineal laceration, grade 1 and 2, during normal delivery submitted to the application of low power laser versus "sham" laser:
- Describe the biological characteristics (age, weight, height, BMI), sociodemographic (marital status, race, years studied, family income, social occupational);
- Describe the characteristics related to life habits (smoking, activity physical, pelvic physiotherapy during pregnancy, Pilates during pregnancy, yoga during pregnancy);
- Describe the previous gynecological and obstetric characteristics (number of pregnancies, type of previous births, number of abortions, suture in childbirth current) and obstetric (prenatal consultations, number of prenatal consultations, gestational age, gestational weight gain, use of oxytocin, use of analgesia, blood flow guidance, position during the second period of childbirth, hours labor, instrumental delivery, birth weight, head circumference of the newborn, shoulder dystocia, perineal laceration, the severity of lacerations, laceration extension, postpartum perineal pain);
- Compare the parameters of REEDA, such as redness, edema, bruising, secretion and approximation of the edges at each intervention and in the range of seven and 42 days after laser application;
- Compare the frequency of perineal pain and genito-pelvic pain at each intervention and between seven and 42 days after laser application;
- Compare the measurement of the extent of perineal laceration, using Peri-Rule, the each intervention and in the interval of seven and 42 days after the application of the laser.
Initially, the study will be carried out with 30 women (pilot study) for later the sample calculation will be carried out. A pilot study will be carried out, as, during the search in the database, no studies were found that address the use of low-level laser in spontaneous perineal lacerations, so that sample calculation was carried out.
Randomization for the intervention and control groups will be performed according to a list of random numbers drawn up for that purpose by an employee who does not was involved with data collection, to ensure confidentiality in the allocation. From this list, sealed and opaque envelopes will be prepared, numbered sequentially, with each number, according to the randomization table, corresponds to the patient's allocation to the intervention or control group.
For statistical analysis of the data, the domain statistical program will be used public Epi-info version 7, or higher versions. Tables will be distributed frequency distribution for categorical variables, calculating the mean and deviation standard of quantitative variables. Then, contingency tables will be used to determine the association of the independent variable (laser application) with the independent variables (REEDA scale, perineal pain, genito-pelvic pain). For determination of the strength of association will be calculated as a measure of the risk (RR) and its 95% confidence interval. All p values will be two-tailed and in all stages of the analysis will be considered a level of significance 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LASER | Experimental | Radiation: LASERIn 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. |
| CONTROL | Sham comparator | Radiation: CONTROLIn 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- Transfer to another sector;
- Performing an episiotomy;
- Evolution to cesarean section;
- Need for curettage;
- Instrumental delivery (use of forceps and vacuum);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASERLaser will be applied in specific points for perineal lacerations. | Radiation | LASER |
| CONTROLA 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. | Radiation | CONTROL |
Primary outcome
SIZE OF LACERATION 6 hours after delivery
Time frame: 6 HOURS
Size in centimeters of the perineal laceration, measured by the PERI-RULE 6 hours after delivery
SIZE OF LACERATION 6 hours after delivery
Time frame: 24 hours after delivery
Size in centimeters of the perineal laceration, measured by the PERI-RULE 24 hours after delivery
SIZE OF LACERATION 6 hours after delivery
Time frame: 48 hours after delivery
Size in centimeters of the perineal laceration, measured by the PERI-RULE 48 hours after delivery
SIZE OF LACERATION AFTER ONE WEEK
Time frame: 1 WEEK
Size in centimeters of the perineal laceration, measured by the PERI-RULE one week after delivery
SIZE OF LACERATION AFTER 42 DAYS
Time frame: 42 DAYS
Size in centimeters of the perineal laceration, measured by the PERI-RULE after 42 days of delivery
35 secondary outcomes
REDNESS AFTER 5 HOURS
Time frame: 6 hours after delivery
REDNESS AFTER 24 HOURS
Time frame: 24 hours after delivery
REDNESS AFTER 48 HOURS
Time frame: 48 hours after delivery
REDNESS AFTER 7 DAYS
Time frame: 7 days
REDNESS AFTER 42 DAYS
Time frame: 42 days
EDEMA AFTER 6 HOURS
Time frame: 6 hours after delivery
EDEMA AFTER 24 HOURS
Time frame: 24 hours after delivery
EDEMA AFTER 48 HOURS
Time frame: 48 hours after delivery
EDEMA AFTER 7 DAYS
Time frame: 7 days
EDEMA AFTER 42 DAYS
Time frame: 42 days
BRUISING AFTER 6 HOURS
Time frame: 6 hours after delivery
BRUISING FATER 24 HOURS
Time frame: 24 hours after delivery
BRUISING AFTER 48 HOURS
Time frame: 48 hours after delivery
BRUISING AFTER 7 DAYS
Time frame: 7 days
BRUISING AFTER 42 DAYS
Time frame: 42 days
PRESENCE OF SECRETION AFTER 6 HOURS
Time frame: 6 hours after delivery
PRESENCE OF SECRETION AFTER 24 HOURS
Time frame: 24 hours after delivery
PRESENCE OF SECRETION AFTER 48 HOURS
Time frame: 48 hours after delivery
PRESENCE OF SECRETION AFTER 7 DAYS
Time frame: 7 days
PRESENCE OF SECRETION AFTER 42 DAYS
Time frame: 42 days
WOUND CLOSURE AFTER 6 HOURS
Time frame: 6 hours after delivery
WOUND CLOSURE AFTER 24 HOURS
Time frame: 24 hours after delivery
WOUND CLOSURE AFTER 48 HOURS
Time frame: 48 hours after delivery
WOUND CLOSURE AFTER 7 DAYS
Time frame: 7 days
WOUND CLOSURE AFTER 42 DAYS
Time frame: 42 days
PERINEAL PAIN AFTER 6 HOURS
Time frame: 6 hours of delivery
PERINEAL PAIN AFTER 24 HOURS
Time frame: 24 hours of delivery
PERINEAL PAIN AFTER 48 HOURS
Time frame: 48 hours of delivery
PERINEAL PAIN AFTER 7 DAYS
Time frame: 7 days of delivery
PERINEAL PAIN AFTER 42 DAYS
Time frame: 42 days of delivery
PELVIC PAIN AFTER 6 HOURS
Time frame: 6 hours of delivery
PELVIC PAIN AFTER 24 HOURS
Time frame: 24 hours of delivery
PELVIC PAIN AFTER 48 HOURS
Time frame: 48 hours of delivery
PELVIC PAIN AFTER 7 DAYS
Time frame: 7 days of delivery
PELVIC PAIN AFTER 42 DAYS
Time frame: 42 days of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melania M Amorim, PhD study director
IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASER in people with Perineal Tear, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIZE OF LACERATION 6 hours after delivery (time frame: 6 HOURS). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.