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Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women (PRP-EpiHeal)

25 de junio de 2026 actualizado por: Brezeanu Dragos, Saint Andrew Hospital Constanta

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Ana Brezeanu, Doctor
  • Número de teléfono: +40727604808

Ubicaciones de estudio

    • Constanța County
      • Constanța, Constanța County, Rumania, 900184
        • Saint Andrew Hospital
        • Contacto:
          • Vlad Tica, Professor
          • Número de teléfono: +40721334543
          • Correo electrónico: vtica@eeirh.org
        • Contacto:
          • Viorel Cristurean, Professor

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Otros nombres:
  • PPR
  • Autologous Platelet Concentrate
Comparador activo: 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.
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.
Otros nombres:
  • Standard Postpartum Wound Care
  • Routine Episiotomy Care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
REEDA Score (Redness, Edema, Ecchymosis, Discharge, Approximation)
Periodo de tiempo: 6 weeks postpartum
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postpartum Perineal Pain (VAS Score)
Periodo de tiempo: At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Vlad Tica, Professor, Ovidius University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

21 de junio de 2026

Finalización primaria (Actual)

21 de junio de 2026

Finalización del estudio (Estimado)

30 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de junio de 2026

Publicado por primera vez (Actual)

25 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PRPEPIHEAL30051990
  • PRP-EpiHeal-2026 (Otro identificador: Ovidius University)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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