Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSaint Andrew Hospital Constanta
About this trial
This study looks at whether a treatment made from a patient's own blood, called platelet-rich plasma (PRP), can help heal the cut made during childbirth (episiotomy) better than standard care alone.
PRP is prepared by drawing a small blood sample from the patient and spinning it in a centrifuge to concentrate the platelets, which contain natural healing factors. In this study, women who have an episiotomy during vaginal delivery will be randomly assigned to one of two groups: one group will receive a single injection of their own PRP at the wound site right after delivery, and the other group will receive the usual standard wound care. Neither group's care will otherwise differ.
Researchers will follow each woman for 6 weeks after delivery, checking how well the wound is healing using a standard scoring tool (REEDA score), along with pain levels, any complications like infection or wound reopening, and how satisfied participants are with their recovery.
The goal is to find out whether this simple, low-risk treatment using a woman's own blood can speed up healing and reduce discomfort after childbirth.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Singular pregnancy, at term (≥ 37 weeks of gestation)
Vaginal delivery with episiotomy (midline or mediolateral)
Signed informed consent to participate in the study
Disqualifiers
Known coagulation disorders or thrombocytopenia (< 100,000/mm³)
Severe anemia (hemoglobin < 7 g/dL) at the time of delivery
Active systemic or local perineal infection at the time of delivery
Uncontrolled diabetes mellitus or other significant comorbidities affecting wound healing (e.g., autoimmune disease under immunosuppressive treatment) Third- or fourth-degree perineal laceration (extending to the anal sphincter or rectal mucosa) Refusal to participate or inability to provide informed consent
Trial design
Treatments tested in this trial
- Autologous Platelet-Rich Plasma (PRP)
- Standard Wound Care
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov