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Laser treatment of the perineum after vaginal delivery

Photobiomodulation Treatment for Perineal Trauma: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-1024tnxh
Enrollment
Unknown
Registered
2025-06-13
Start date
2024-04-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Period

Interventions

Randomized, controlled, two-arm, double-blind clinical trial. The 74 postpartum women with perineal trauma will be randomly allocated using the Randomizer+ application into two intervention groups: Ph
E07.632.490

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Hospital São Lucas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 45 years old. Full term vaginal birth. First pregnancy. Body Mass Index appropriate according to gestational age according to the body mass index classification by Atalah and collaborators

Exclusion criteria

Exclusion criteria: Smoking and alcoholism. Gestational diabetes mellitus, hypertensive syndromes or autoimmune diseases. Postpartum hemorrhage. Bacterial infection or sexually transmitted disease. History of vulvar and vaginal surgery. Previous history of gynecological câncer. Presence of metallic implants in the pelvic region. Women with a recent history of urinary tract infection. Neurological changes. Using corticosteroid therapy. Withdrawal from the protocol

Design outcomes

Primary

MeasureTime frame
It is expected that the treatment group will present less intensity of perineal pain than the placebo group.

Secondary

MeasureTime frame
It is expected that the treatment group will present better perineal healing than the placebo group

Countries

Brazil

Contacts

Public ContactLaís de Sousa

Universidade Federal de São Paulo

lais.gaspar@unifesp.br+55 (11) 3385-4255

Outcome results

None listed

Source: REBEC (via WHO ICTRP)