Photobiomodulation for Episiotomies and Perineal Lacerations After Vaginal Delivery.
Launched by UNIVERSITY OF NOVE DE JULHO · Mar 18, 2025
Trial Information
Current as of April 29, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a treatment called Photobiomodulation (PBM) on women who have experienced episiotomies (a surgical cut made during childbirth) or perineal lacerations (tears in the perineum) after vaginal delivery. The goal is to see if PBM can help reduce pain and improve healing compared to standard treatments like pain medications, ice packs, and baths. Women who are 18 years or older, have had a vaginal birth, and experienced a grade 2 or 3 tear or an episiotomy may be eligible to participate.
During the hospital stay after delivery, participants can choose to receive PBM therapy in addition to the regular care they would normally get. The study will compare the pain levels and healing progress of those who receive PBM with those who do not. Participants will be asked to rate their pain and healing at different times to gather information on how effective PBM is. It's important to note that women with certain complications, multiple pregnancies, or specific health issues may not be eligible for this trial.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Adult women over 18 years of age;
- • Parturients with a gestational age equal to or greater than 37 weeks;
- • Patients who had a vaginal birth;
- • Patients undergoing episiotomy or patients who presented grade 2 or 3 perineal laceration during childbirth.
- Exclusion Criteria:
- • Multiple pregnancy (twins);
- • Presence of fetal malformation or death identified during prenatal care or at the time of hospitalization for delivery;
- • Patients with serious complications such as severe puerperal hemorrhage or HELLP Syndrome during childbirth.
- • Patients with grade 1 or 4 perineal lacerations.
- • Presence of systemic diseases that alter the repair process.
- • Withdrawal of the nformed Consent Form" (ICF) at the request of the patient or those responsible;
About University Of Nove De Julho
The University of Nove de Julho (UNINOVE) is a prestigious educational institution located in São Paulo, Brazil, renowned for its commitment to advancing research and innovation in the field of health sciences. As a clinical trial sponsor, UNINOVE aims to foster collaboration between academia and the healthcare industry, facilitating the development and evaluation of novel therapeutic interventions. With a robust infrastructure and a team of experienced researchers, the university is dedicated to conducting high-quality clinical trials that adhere to rigorous ethical standards and regulatory guidelines, ultimately contributing to improved health outcomes and the enhancement of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ponta Grossa, Paraná, Brazil
Patients applied
Trial Officials
Rebeca B Cecatto, PhD
Study Director
University of Nove de Julho
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported