EpisiotomyPRP-EpiHealNCT07669285
Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
A study testing Autologous Platelet-Rich Plasma (PRP) and Standard Wound Care in people with Episiotomy and Platelet Rich Plasma (PRP), run by Saint Andrew Hospital Constanta at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy, Platelet Rich Plasma (PRP), Wound Healing
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP) and Standard Wound Care
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 21 Jun 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ana Brezeanu, Doctor contact
Romania1 site
Saint Andrew Hospital
Constanța, Constanța County, 900184
Vlad Tica, Professor, +40721334543, vtica@eeirh.org
Viorel Cristurean, Professor
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Episiotomy, Platelet Rich Plasma (PRP), Wound Healing, Obstetric
- Being tested
- Autologous Platelet-Rich Plasma (PRP), Standard Wound Care
- Keywords
- episiotomy, platelet rich plasma, wound healing, obstetric, postpartum period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma (PRP)Biological
Also called PRP, Autologous Platelet Concentrate
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.
Standard Wound CareProcedure or surgery
Also called Standard Postpartum Wound Care, Routine Episiotomy 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks postpartum
Secondary outcomes (1)
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.
Measured: At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start21 Jun 2026 (estimated)
- Primary completion21 Jun 2026
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Andrew Hospital Constanta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brezeanu Dragos, Saint Andrew Hospital Constanta
- Investigators
- Vlad Tica, Professor, Study director, Ovidius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669285
- Sponsor's protocol ID
- PRPEPIHEAL30051990
- Other IDs
- PRP-EpiHeal-2026
- Acronym
- PRP-EpiHeal
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41302293Brezeanu 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.
PubMed 41302316Brezeanu D, Brezeanu AM, Surdu TV, Surdu M, Tica V. Platelet-Rich Plasma in Episiotomy Repair: A Critical Appraisal of a Sparse and Partly Non-Indexed Evidence Base and Rationale for a Randomized Controlled Trial. Life (Basel). 2026 Aug 15;16(8):1339. doi: 10.3390/life16081339.
PubMed 42653027
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Autologous Platelet-Rich Plasma in Enhancing Episiotomy Wound Healing and Reducing Postpartum Perineal Pain: A Prospective Randomized Controlled Trial (PRP-EpiHeal)
- ClinicalTrials.gov ID
- NCT07669285
- Acronym / sponsor ID
- PRP-EpiHeal / PRPEPIHEAL30051990
- Conditions
- Episiotomy, Platelet Rich Plasma (PRP), Wound Healing, Obstetric
- Keywords
- episiotomy, platelet rich plasma, wound healing, obstetric, postpartum period
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Saint Andrew Hospital ConstantaUniversity, hospital or other
- Study start
- 21 Jun 2026 (estimated)
- Primary completion
- 21 Jun 2026 (actual)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Biological: Autologous Platelet-Rich Plasma (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. |
| Standard Care | Active comparator | Procedure: Standard Wound CareRoutine postpartum care of the episiotomy wound according to the institution's standard protocol (local hygiene, standard analgesia), without any additional biological intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP)Also: PRP, Autologous Platelet ConcentratePRP 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. | Biological | PRP |
| Standard Wound CareAlso: Standard Postpartum Wound Care, Routine Episiotomy CareParticipants 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. | Procedure or surgery | Standard Care |
Primary outcome
REEDA Score (Redness, Edema, Ecchymosis, Discharge, Approximation)
Time frame: 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.
1 secondary outcome
Postpartum Perineal Pain (VAS Score)
Time frame: At 24-48 hours, 7 days, 2 weeks, and 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 41302293Brezeanu 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.
- Background: PubMed 41302316Brezeanu 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.
- Derived from this study: PubMed 42653027Brezeanu D, Brezeanu AM, Surdu TV, Surdu M, Tica V. Platelet-Rich Plasma in Episiotomy Repair: A Critical Appraisal of a Sparse and Partly Non-Indexed Evidence Base and Rationale for a Randomized Controlled Trial. Life (Basel). 2026 Aug 15;16(8):1339. doi: 10.3390/life16081339.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Brezeanu, Doctor contact
Vlad Tica, Professor study director
Ovidius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma (PRP) and Standard Wound Care in people with Episiotomy and Platelet Rich Plasma (PRP), run by Saint Andrew Hospital Constanta at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dragos Brezeanu, Doctor (+40756508303, brezeanudragos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REEDA Score (Redness, Edema, Ecchymosis, Discharge, Approximation) (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669285, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.