Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women

ConditionsEpisiotomy Platelet Rich Plasma (PRP)Wound Healing Obstetric

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Autologous Platelet-Rich Plasma (PRP)
Biological/Vaccine
PRP is prepared from autologous peripheral venous blood collected from the participant at the time of delivery, processed by centrifugation to yield a platelet concentration above baseline whole-blood levels. The resulting PRP is administered as a single local injection into the tissue at the margins and base of the episiotomy wound, performed intraoperatively or immediately postpartum, before or shortly after suture closure. No additional PRP doses are administered after this single application, and no exogenous activating agents are used.
Standard Wound Care
Procedure/Surgery
Participants in this arm receive routine postpartum care of the episiotomy wound, consisting of local hygiene measures (perineal cleansing, sitz baths as per institutional practice) and standard analgesia for postpartum perineal pain, without any additional biological, pharmacological, or procedural intervention targeting wound healing. No PRP, growth factor concentrate, topical wound-healing agent, or other regenerative product is applied.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: PRPExperimental treatment 1 intervention

Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

REEDA Score (Redness, Edema, Ecchymosis, Discharge, Approximation)

The REEDA scale is a validated tool for objective assessment of perineal wound healing, scoring five components - redness, edema, ecchymosis, discharge, and approximation of wound edges - each rated from 0 to 3, yielding a total score ranging from 0 (optimal healing) to 15 (poor healing). The REEDA score will be assessed by the outcomes assessor, blinded to treatment allocation, at the standard 6-week postpartum visit, and compared between the PRP arm and the standard care arm.

Time frame

6 weeks postpartum

Secondary outcomes

Postpartum Perineal Pain (VAS Score)

Pain intensity at the episiotomy site, self-reported using a 0-10 Visual Analog Scale (VAS), compared between arms at each time point.

Time frame

At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint Andrew Hospital Constanta

Lead sponsor

Source ClinicalTrials.gov

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