- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07669285
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dragos Brezeanu, Doctor
- Telefonní číslo: +40756508303
- E-mail: brezeanudragos@gmail.com
Studijní záloha kontaktů
- Jméno: Ana Brezeanu, Doctor
- Telefonní číslo: +40727604808
Studijní místa
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Constanța County
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Constanța, Constanța County, Rumunsko, 900184
- Saint Andrew Hospital
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Kontakt:
- Vlad Tica, Professor
- Telefonní číslo: +40721334543
- E-mail: vtica@eeirh.org
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Kontakt:
- Viorel Cristurean, Professor
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
Ostatní jména:
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Aktivní komparátor: 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.
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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REEDA Score (Redness, Edema, Ecchymosis, Discharge, Approximation)
Časové okno: 6 weeks postpartum
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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.
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6 weeks postpartum
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postpartum Perineal Pain (VAS Score)
Časové okno: At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum
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Pain intensity at the episiotomy site, self-reported using a 0-10 Visual Analog Scale (VAS), compared between arms at each time point.
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At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Vlad Tica, Professor, Ovidius University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- PRPEPIHEAL30051990
- PRP-EpiHeal-2026 (Jiný identifikátor: Ovidius University)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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