💬In plain words
What the trial is, and whether it could suit you
Postoperative pain following cesarean section remains a major clinical challenge that can impair early maternal recovery, delay ambulation, and interfere with newborn care. Photobiomodulation (PBM) is a non-invasive light therapy that uses red and near-infrared light to reduce inflammation, stimulate cellular energy (ATP) production, and promote tissue repair. The purpose of this randomized, double-blind, sham-controlled clinical trial is to evaluate the efficacy and safety of portable photobiomodulation using the MitoQUAD® device as an adjunct to standard multimodal analgesia in postpartum women undergoing cesarean section. Participants (N=210) will be randomized (1:1) to receive either active PBM or a sham device in three 15-minute sessions (at 30 minutes, 24 hours, and 36-48 hours post-cesarean). Pain intensity, rescue analgesic use, wound healing, time to ambulation, maternal satisfa
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Provided written informed consent prior to any study-related procedure.
2. Aged between 18 and 40 years at the time of enrollment.
3. Singleton pregnancy with a gestational age between 37+0 and 41+6 weeks confirmed by first-trimester ultrasound or reliable last menstrual period.
4. Single fetus in cephalic presentation.
5. Scheduled or emergency primary or repeat low-transverse segment cesarean section (maximum 1 prior cesarean delivery) performed via Pfannenstiel incision.
6. Received neuraxial anesthesia (spinal, epidural, or combined spinal-epidural) according to institutional protocol.
7. Skin closure executed using standardized technique (absorbable intradermal suture, nylon, or surgical staples).
Exclusion Criteria:
1. Pregestational diabetes mellitus or gestational diabetes requiring insulin therapy or with inadequate glycemic control.
2. Medical conditions affecting normal wound healing or inflammatory response (e.g., systemic lupus erythematosus, scleroderma, immunodeficiencies, or chronic systemic corticosteroid/immunosuppressive therapy).
3. Active chorioamnionitis, sepsis, active systemic infection, or pre-existing skin infection at the surgical site.
4. Complicated cesarean delivery with operative time exceeding 90 minutes, surgical drain placement, or intraoperative organ injury.
5. History of severe keloid formation or known abdominal hypertrophic scarring disorders.
6. Chronic pain syndromes, fibromyalgia, chronic opioid use, or history of substance abuse.
7. Intraoperative conversion to general anesthesia or failure of planned neuraxial anesthesia.
8. Body Mass Index (BMI) ≥ 40 kg/m² at late pregnancy.
9. Known hypersensitivity or allergy to materials used in the photobiomodulation device or dressing.
10. Concurrent participation in another clinical trial or receipt of an investigational product within 30 days prior to enrollment.
11. Any significant medical, obstetric, or psychiatric condition that, in the judgment of the Principal Investigator, could compromise participant safety or protocol compliance.
💊
What it tests
- Photobiomodulation Therapy (MitoQUAD® Belt System)
- Sham Photobiomodulation Device
Hospital Escuela
Tegucigalpa, Honduras
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky