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Набор скоро начнётся NCT07669285

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

Без фазы С лечением Episiotomy Platelet Rich Plasma (PRP) Wound Healing Obstetric

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Autologous Platelet-Rich Plasma (PRP), Standard Wound Care.
Кому может быть актуально
Состояния в реестре: Episiotomy, Platelet Rich Plasma (PRP), Wound Healing, Obstetric. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Румыния
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Биопрепарат 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
  • Процедура 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.

Первичные конечные точки

  • REEDA Score (Redness, Edema, Ecchymosis, Discharge, Approximation) [Срок оценки: 6 weeks postpartum]
Вторичные конечные точки (1)
  • Postpartum Perineal Pain (VAS Score) [Срок оценки: At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Румыния · 1 центр
  • Saint Andrew Hospital — Constanța

Публикации

  • 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
  • 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

Идентификаторы

NCT: NCT07669285 · PRPEPIHEAL30051990 · PRP-EpiHeal-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗