Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Random… (NCT07480083) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Randomized Clinical Trial.
Brazil206 participantsStarted 2026-04-01
Plain-language summary
This randomized clinical trial aims to evaluate the effectiveness of low-level laser therapy compared with sham treatment on pain intensity and perineal wound healing quality in the immediate postpartum period. The study seeks to determine whether low-level laser therapy can reduce perineal pain and improve healing outcomes in women with perineal trauma after vaginal birth.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Postpartum women/multiparous women aged 18 years or older;
Postpartum women/multiparous women in the immediate postpartum period after vaginal birth;
Postpartum women/multiparous women with spontaneous perineal laceration (Grade II, III, or IV);
Postpartum women/multiparous women with an average pain score of at least 3 on the Visual Analog Scale (VAS);
Labor duration up to 18 hours.
Exclusion Criteria:
Postpartum women/multiparous women classified as high-risk during pregnancy due to a diagnosis of gestational diabetes mellitus; type 1 or type 2 diabetes mellitus; chronic or pregnancy-specific hypertension; smoking; alcohol use; use of psychoactive substances, among others;
Postpartum women/multiparous women who present postpartum complications (such as hemorrhage, difficulty in verbal communication, or sepsis);
Postpartum women/multiparous women who develop clinical or hemodynamic complications after childbirth;
Postpartum women/multiparous women whose newborns died or were admitted to a Neonatal Intensive Care Unit (NICU);
Women with communication difficulties (impaired understanding or mental disorders).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perineal pain intensity (VAS) (immediate)
Timeframe: 30 minutes
2
Perineal Pain Intensity (VAS) - 24 hours
Timeframe: 24 hours
3
Perineal Pain Intensity (VAS) - 48 Hours
Timeframe: 48 Hours
4
Assessment of wound healing (REEDA) - immediate
Timeframe: 30 minutes
5
Assessment of Wound Healing (REEDA) - 24 Hours
Timeframe: 24 Hours
Trial details
NCT IDNCT07480083
SponsorInstituto Materno Infantil Prof. Fernando Figueira