Use of infrared laser in vaginal delivery

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-9zxb97
• Date of registration: 21/06/2011
• Primary sponsor: Financiamento próprio, bolsa mestrado CAPES - Brazil
• Public title: Use of infrared laser in vaginal delivery
• Scientific title: Use of infrared laser in vaginal delivery with episiotomy: randomized controlled trial
• Date of first enrolment: 01/05/2011
• Target sample size: 50
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-9zxb97/
• Study design: Clinical trial, parallel, randomized and controlled.

Countries of recruitment

Brazil

Contacts

• Name: Sonia Maria de Oliveira
• Affiliation: Escola de Enfermagem da Universidade de São Paulo

• Name: Marina Alvarenga
• Affiliation: Escola de Enfermagem da Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Healthy women aged over 18 years; with term pregnancy (between 37 and 41 weeks and 6 days of gestation);without previous vaginal birth; having had spontaneous delivery with mediolateral episiotomy without perineal laceration; episiorrhaphy performed with catgut simple; Single fetus in cephalic presentation and live; not presenting an infectious disease, hemorrhoids, bruising or varicose veins in vulvo-perineal region; did not have any preparation of the perineal area during pregnancy; do not use drugs photosensitising endogenous or exogenous; not present clinical or obstetric complications.
Exclusion criteria: Use any product in vulvo-perineal region, other than soap and water

Age minimum: 18Y
Age maximum: 0
Gender: F

Health Condition(s) or Problem(s) studied

Healing of episiotomies
E04.520.252.750
A01.719
G08.686.702

Intervention(s)

Sample - 50 women divided into 2 groups (25 in the control group and 25 in the experimental group).
Intervention - laser irradiation at low intensity in healthy women with episiotomies.
Experimental group: 25 patients will undergo three irradiations on perineal area (energy density 5J/cm2, power 20 mW) in 9 points (3 on episiotomy, third from the right side and three on the left side) lasting 10 seconds for each point. Interventions occur 6 to 10 hours after delivery, 20 to 24 hours and 40 to 48 hours after the first irradiation with a total of 0.2 J per point and a total energy of 1.8 J per session.
In the control group, the procedures are the same, but without laser irradiation, using a probe which only emits a light guide.

Primary Outcome(s)

Episiotomy healing will be evaluated before the three irradiations and 7 to 10 days after after discharge, with a numerical scale that quantifies the redness, edema ,ecchymosis, discharge and approximation of wound edges (Scale REEDA- Redness Edema Echymosis Discharge Aproximation).

Secondary Outcome(s)

The intensity of pain will be evaluated by numerical scale from 0 to 10, with 0 is equal to no pain and 10 is the maximum pain.
The evaluation will be done before and 30 minutes after irradiations.

Secondary ID(s)

1006/2011/CEP-EEUSP