Status:
SUSPENDED
Low Power Laser for Spontaneous Perineal Laceration
Lead Sponsor:
Instituto Materno Infantil Prof. Fernando Figueira
Conditions:
Perineal Tear
Eligibility:
FEMALE
Phase:
NA
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 s...
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: 1. Describe the biological charac...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04914182
Start Date
June 3 2021
End Date
October 1 2024
Last Update
May 31 2023
Active Locations (1)
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1
Maternidade Professor Barros Lima
Recife, Pernambuco, Brazil, 52070-660