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

NCT07669285 | Not Yet Recruiting DMC

• 2 other identifiers: PRPEPIHEAL30051990PRP-EpiHeal-2026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Episiotomy; Platelet Rich Plasma (PRP); Wound Healing; Obstetric

Keywords

episiotomy; platelet rich plasma; wound healing; obstetric; postpartum period

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks postpartum

Secondary Outcomes (1)

• Postpartum Perineal Pain (VAS Score)

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

Study Arms (2)

PRP

EXPERIMENTAL

Participants receive a single local injection of autologous platelet-rich plasma (PRP) at the episiotomy wound site, administered intraoperatively or immediately postpartum, in addition to standard postpartum wound care.

Biological: Autologous Platelet-Rich Plasma (PRP)

Standard Care

ACTIVE COMPARATOR

Routine postpartum care of the episiotomy wound according to the institution's standard protocol (local hygiene, standard analgesia), without any additional biological intervention.

Procedure: Standard Wound Care

Interventions

Autologous Platelet-Rich Plasma (PRP) BIOLOGICAL

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.

Also known as: PRP, Autologous Platelet Concentrate

PRP

Standard Wound Care PROCEDURE

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.

Also known as: Standard Postpartum Wound Care, Routine Episiotomy Care

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is restricted to individuals who have given birth vaginally and undergone an episiotomy, a procedure performed exclusively in the context of vaginal childbirth. Participation therefore requires the biological capacity for vaginal delivery; eligibility is not restricted by gender identity, but by the clinical event (vaginal delivery with episiotomy) that defines the study population.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Andrew Hospital Constanta: lead

Study Sites (1)

Saint Andrew Hospital

Constanța, Constanța County, 900184, Romania

Location

Related Publications (2)

• Brezeanu AM, Brezeanu D, Stase S, Chirila S, Tica VI. Intraoperative Platelet-Rich Plasma Application Improves Scar Healing After Cesarean Section: A Prospective Observational Pilot Study. Healthcare (Basel). 2025 Nov 14;13(22):2905. doi: 10.3390/healthcare13222905.

  PMID: 41302293 BACKGROUND

• Brezeanu AM, Brezeanu D, Tica VI. Intraoperative Platelet-Rich Plasma (PRP) for Post-Cesarean Scar Healing: A Single-Center Randomized Controlled Pilot Study. Healthcare (Basel). 2025 Nov 15;13(22):2928. doi: 10.3390/healthcare13222928.

  PMID: 41302316 BACKGROUND

Study Officials

• Vlad Tica, Professor

  Ovidius University

  STUDY DIRECTOR

Central Study Contacts

Dragos Brezeanu, Doctor

CONTACT

+40756508303; brezeanudragos@gmail.com

Ana Brezeanu, Doctor

CONTACT

+40727604808

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor responsible for evaluating the primary endpoint (REEDA score at 6 weeks postpartum) is blinded to treatment allocation. This assessor is a clinician not involved in the delivery, the PRP preparation or injection, or any other aspect of the participant's intrapartum care, and has no access to the randomization record or to information indicating which arm the participant was assigned to. Participants are instructed not to disclose their treatment assignment to the assessor during the evaluation visit. Because the injection site area is similarly prepared and dressed in both arms following the procedure, visual inspection of the wound at the time of REEDA scoring does not reveal which intervention was received. Participants themselves, the clinical team performing the delivery and the PRP injection, and the investigators are not blinded to treatment allocation, given the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a two-arm, parallel-group, randomized controlled trial. Eligible women who undergo a vaginal delivery with episiotomy are randomly assigned in a 1:1 ratio, using a computer-generated block randomization sequence with concealed allocation, to one of two parallel arms: an experimental arm receiving a single local injection of autologous platelet-rich plasma (PRP) at the episiotomy wound site immediately after delivery, or a control arm receiving standard wound care alone. Both arms otherwise receive identical routine postpartum care and follow-up. The study is open-label, as the nature of the intervention does not allow for blinding of the clinical team; outcome assessment of the primary endpoint (REEDA score) will be performed, where feasible, by an evaluator independent of the treating team to reduce assessment bias.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: June 21, 2026
• Primary Completion: June 21, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start Date: Beginning approximately 9-12 months after publication of the primary study results (allowing time for completion of the primary analysis and manuscript publication). End Date: No end date; data will remain available indefinitely upon reasonable request, subject to the access criteria described above.
• Access Criteria: Qualified researchers affiliated with an academic, clinical, or research institution, who submit a written request describing a specific scientific purpose for which the data will be used

Locations

RO (1)