Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women: A Randomized Controlled Trial (PRP-EpiHeal)

Efficacy of Autologous Platelet-Rich Plasma in Enhancing Episiotomy Wound Healing and Reducing Postpartum Perineal Pain: A Prospective Randomized Controlled Trial (PRP-EpiHeal)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Episiotomy; Wound Healing; Platelet Rich Plasma (PRP); Obstetric
• Intervention / Treatment: Biological: Autologous Platelet-Rich Plasma (PRP); Procedure: Standard Wound Care

Detailed Description

Background An episiotomy is a small surgical cut made at the vaginal opening during childbirth to help the baby pass through more easily. It is one of the most common procedures performed during vaginal delivery. While most episiotomy wounds heal without problems, a meaningful number of women experience complications such as swelling, bruising, discharge, delayed wound closure, or infection. These complications can cause ongoing pain, make it harder to sit, walk, care for a newborn, or breastfeed comfortably, and can affect a woman's overall recovery and quality of life in the weeks after birth.

Current care for episiotomy wounds is mostly supportive: keeping the area clean, managing pain with medication, and waiting for the body to heal naturally. There is currently no widely used treatment that actively speeds up or improves the quality of healing for this specific type of wound.

What is PRP, and why might it help? Platelet-rich plasma (PRP) is a substance prepared from a person's own blood. A small blood sample is drawn and processed in a centrifuge, which separates and concentrates the platelets - tiny blood cells that play a central role in clotting and tissue repair. Platelets release natural growth factors that help recruit the body's repair processes, encourage new tissue and blood vessel formation, and reduce excessive inflammation.

Because PRP comes from the patient's own blood, it carries a very low risk of allergic reaction or infection transmission, unlike treatments derived from another person or from synthetic materials. PRP has already been used with encouraging results in other fields of medicine - orthopedics, sports medicine, and plastic surgery - to help wounds and injuries heal. It has also shown early promise in helping cesarean section wounds heal better, based on the research team's prior work in that area. However, no large, rigorously designed study has yet tested whether a single PRP injection can improve healing specifically for episiotomy wounds. This study is designed to fill that gap.

What will happen in the study?

Women who deliver vaginally and require an episiotomy will be invited to take part. Those who agree and meet the study's eligibility criteria will be randomly assigned - similar to a coin flip, using a computer-generated process - to one of two groups:

PRP group: Right after delivery, a small blood sample is drawn and processed into PRP, which is then injected once into the tissue at the edges and base of the episiotomy wound, either just before or just after the wound is stitched closed.

Standard care group: The wound is stitched and cared for using the hospital's usual approach, without any PRP injection.

Apart from this one difference, both groups receive the same routine postpartum care, pain management, and hygiene guidance.

What will be measured?

All participants will be followed for six weeks after giving birth, with check-ins at several points: within the first two days, at one week, at two weeks, and at the standard six-week postpartum visit. At each visit, the research team will assess:

How well the wound is healing, using a standardized, objective scoring tool (the REEDA scale), which looks at redness, swelling, bruising, discharge, and how well the wound edges have come together.

Pain levels, using a simple 0-10 pain rating scale. Whether any complications occur, such as the wound reopening (dehiscence) or becoming infected.

How quickly women feel able to resume their normal daily activities. Overall satisfaction with how the wound healed, gathered through a short questionnaire at the six-week visit.

Any side effects related to the PRP injection itself, to confirm the procedure's safety.

Why this study matters If a single, low-cost injection using a woman's own blood can meaningfully improve how episiotomy wounds heal - with less pain, fewer complications, and faster recovery - this could become a simple addition to routine delivery care that benefits a very large number of women worldwide. Because PRP is autologous (derived from the patient herself), the safety profile is expected to be favorable, making this a particularly attractive option to study rigorously before considering wider clinical use.

This study takes place at two hospitals in Constanța, Romania (Armonia Hospital and the Constanța County Emergency Clinical Hospital), and is conducted by a research team affiliated with "Ovidius" University of Constanța with prior experience studying PRP in postpartum wound healing.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dragos Brezeanu, Doctor; Phone Number: +40756508303; Email: brezeanudragos@gmail.com
• Study Contact Backup: Name: Ana Brezeanu, Doctor; Phone Number: +40727604808

Study Locations

• Romania
  • Constanța County
    • Constanța, Constanța County, Romania, 900184
      • Saint Andrew Hospital
      • Contact: Vlad Tica, Professor; Phone Number: +40721334543; Email: vtica@eeirh.org
      • Contact: Viorel Cristurean, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP; 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); 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.; Other Names: PRP; Autologous Platelet Concentrate
Active Comparator: Standard Care; 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; 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.; Other Names: Standard Postpartum Wound Care; Routine Episiotomy Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Saint Andrew Hospital Constanta
• Investigators: Study Director: Vlad Tica, Professor, Ovidius University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 21, 2026
• Primary Completion (Actual): June 21, 2026
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: wound healing; platelet rich plasma; obstetric; episiotomy; postpartum period
• Other Study ID Numbers: PRPEPIHEAL30051990; PRP-EpiHeal-2026 (Other Identifier: Ovidius University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the primary and secondary outcomes reported in the published results will be made available, including: REEDA score components and totals at each assessment time point; VAS pain scores at each follow-up visit; data on wound dehiscence, infection, and other adverse events; time to resumption of usual daily activities; and maternal satisfaction questionnaire responses. Demographic and baseline clinical characteristics (age, parity, gestational age, type of episiotomy) will also be shared to allow subgroup analysis. The study protocol, statistical analysis plan, and informed consent form will be made available alongside the dataset. Data identifying individual participants (names, exact dates of birth, addresses, or other direct identifiers) will not be shared under any circumstances.

IPD Sharing 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.

• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No