An interventional study of Autologous Non-Activated Platelet-Rich Plasma and Saline (0.9%, sterile, for infusion) in Perineal Trauma, Postpartum Pain and Episiotomy, sponsored by University Hospital, Geneva. Not yet recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Treatment
Perineal tears and episiotomies are common after vaginal birth and may cause persistent pain, impaired wound healing, pain during sexual activity, and concerns about genital appearance.
Platelet-rich plasma (PRP) is prepared from a participant's own blood and contains a concentrated amount of platelets that release growth factors that may support tissue repair. The purpose of this study is to determine whether a single local injection of autologous non-activated PRP during the primary repair of a perineal tear and/or an episiotomy reduces postpartum perineal pain compared with an injection of 0.9% sodium chloride solution.
Participants will be randomly assigned in a 1:1 ratio to receive PRP or saline. Participants, the clinician administering the injection, the clinicians assessing the outcomes, and the statistician will be unaware of the assigned treatment. Follow-up will assess perineal pain, wound healing, scar quality, sexual function, genital self-image, and safety through 6 months postpartum.
The study hypothesis is that PRP will reduce average perineal pain at 3 months postpartum compared with saline.
RELIEVE is a prospective, single-centre, randomized, placebo-controlled, parallel-group trial conducted at the University Hospitals of Geneva.
Adults aged 18 years or older who have a vaginal birth with a second-degree or more severe perineal tear and/or an episiotomy will be randomised in a 1:1 ratio. Randomisation will be stratified by mode of vaginal birth, defined as spontaneous or operative vaginal birth, using randomly permuted blocks.
After closure of the deeper perineal layers and before skin closure, participants will receive a single local injection of either 4-5 mL of autologous non-activated platelet-rich plasma or the same volume of 0.9% sodium chloride solution.
The primary outcome is average perineal pain during the preceding week, measured using a 100-mm visual analogue scale at 12 weeks postpartum. Secondary assessments will evaluate perineal pain, wound healing, scar quality, wound dehiscence, sexual function, genital self-image, and safety at prespecified postpartum time points through 24 weeks.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 160 is above the median of 63 across 126 interventional studies indexed under Dyspareunia.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single local perineal injection of 4-5 mL of 0.9% sodium chloride solution during primary repair of a second-degree or more severe perineal tear and/or episiotomy, after closure of the deeper layers and before skin closure.
Drug: Saline (0.9%, sterile, for infusion)
Participants will receive a single local perineal injection of 4-5 mL of autologous non-activated platelet-rich plasma during primary repair of a second-degree or more severe perineal tear and/or episiotomy, after closure of the deeper layers and before skin closure.
Biological: Autologous Non-Activated Platelet-Rich Plasma
Autologous non-activated platelet-rich plasma will be prepared from venous blood using the RegenBCT-3 system. Approximately 4-5 mL will be injected locally into the subcutaneous and mucosal tissues of the perineal wound using a 27-gauge needle, with approximately 0.1 mL administered at each injection point spaced approximately 5-10 mm apart on both sides of the wound. The intervention will be administered once, within 5 hours after vaginal birth, after closure of the deeper layers and before skin closure.
Also known as: RegenPRP, RegenBCT-3, PRP
Approximately 4-5 mL of sterile 0.9% sodium chloride solution will be injected locally into the subcutaneous and mucosal tissues of the perineal wound using the same injection technique, volume, timing, and anatomical distribution as the experimental intervention. The injection will be administered once, within 5 hours after vaginal birth, after closure of the deeper layers and before skin closure.
Also known as: Normal saline
Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum
Participants will rate their average perineal pain during the preceding 7 days using a 100-mm horizontal visual analogue scale. The scale ranges from 0 mm, indicating no pain, to 100 mm, indicating the worst pain imaginable. Higher scores indicate greater pain.
Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks
Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Weeks Postpartum
Participants will rate their average perineal pain during the preceding 7 days using a 100-mm horizontal visual analogue scale. The scale ranges from 0 mm, indicating no pain, to 100 mm, indicating the worst pain imaginable. Higher scores indicate greater pain.
Time frame: Day 21 postpartum, with an assessment window of ±3 days
Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 6 Months Postpartum
Participants will rate their average perineal pain during the preceding 7 days using a 100-mm horizontal visual analogue scale. The scale ranges from 0 mm, indicating no pain, to 100 mm, indicating the worst pain imaginable. Higher scores indicate greater pain.
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Perineal Wound Healing Assessed by the REEDA Scale at 3 Weeks Postpartum
Perineal wound healing will be assessed using the Redness, Edema, Ecchymosis, Discharge, and Approximation scale. Each of the five items is scored from 0 to 3, giving a total score ranging from 0 to 15. Higher scores indicate poorer wound healing.
Time frame: Day 21 postpartum, with an assessment window of ±3 days
Perineal Wound Healing Assessed by the REEDA Scale at 3 Months Postpartum
Perineal wound healing will be assessed using the Redness, Edema, Ecchymosis, Discharge, and Approximation scale. Each of the five items is scored from 0 to 3, giving a total score ranging from 0 to 15. Higher scores indicate poorer wound healing.
Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks
Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Weeks Postpartum
Scar quality will be assessed by a masked clinician using the 7-item Patient and Observer Scar Assessment Scale 3.0 Observer Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. The total score ranges from 7 to 35. Higher scores indicate poorer clinician-rated scar quality.
Time frame: Day 21 postpartum, with an assessment window of ±3 days
Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Months Postpartum
Scar quality will be assessed by a masked clinician using the 7-item Patient and Observer Scar Assessment Scale 3.0 Observer Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. The total score ranges from 7 to 35. Higher scores indicate poorer clinician-rated scar quality.
Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks
Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Weeks Postpartum
Participants will assess scar appearance, symptoms, and functional characteristics using the POSAS 3.0 Patient Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. Lower scores indicate better patient-rated scar quality. The score will be calculated according to the POSAS 3.0 scoring instructions.
Time frame: Day 21 postpartum, with an assessment window of ±3 days
Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Months Postpartum
Participants will assess scar appearance, symptoms, and functional characteristics using the POSAS 3.0 Patient Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. Lower scores indicate better patient-rated scar quality. The score will be calculated according to the POSAS 3.0 scoring instructions.
Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks
Sexual Function Assessed by the Female Sexual Function Index
Sexual function during the preceding 4 weeks will be assessed using the 19-item Female Sexual Function Index. The instrument evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2 to 36, with higher scores indicating better sexual function. Participants may choose not to complete this sensitive questionnaire.
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Sexual Pain Assessed by the Female Sexual Function Index Pain Domain
Pain and discomfort during or following vaginal penetration during the preceding 4 weeks will be assessed using the three-item pain domain of the Female Sexual Function Index. The domain score ranges from 0 to 6. Higher scores indicate less pain and better sexual function.
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Genital Self-Image Assessed by the Female Genital Self-Image Scale
Genital self-image will be assessed using the 7-item Female Genital Self-Image Scale. Each item is rated from 1, strongly disagree, to 4, strongly agree. The total score ranges from 7 to 28, with higher scores indicating a more positive genital self-image.
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Number of Participants With a Perineal Infection
Perineal infection will be identified from clinical findings, including purulent discharge or other protocol-defined signs of infection, perineal abscess, cellulitis, or another clinically diagnosed infection involving the perineal wound.
Time frame: From the study injection through 24 weeks postpartum
Number of Participants With an Injection-Site Haematoma
Number of Participants With an Injection-Site Haematoma
Time frame: Within 72 hours after vaginal birth
Number of Participants With a Serious Adverse Event
Serious adverse events will be defined according to International Council for Harmonisation criteria and will include events resulting in death, being life-threatening, requiring or prolonging hospitalisation, causing persistent or significant disability, or constituting another important medical event (safety outcome).
Time frame: From the study injection through 24 weeks postpartum
Proportion of Participants With Moderate or Severe Perineal Wound Dehiscence at 3 Months Postpartum
Moderate or severe perineal wound dehiscence is defined as a score of 2 or 3 on the approximation item of the REEDA scale. A score of 2 indicates separated wound edges with the underlying tissues still in contact, and a score of 3 indicates separated wound edges with the underlying tissues not in contact.
Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks
Proportion of Participants With Moderate or Severe Perineal Wound Dehiscence at 3 Weeks Postpartum
Moderate or severe perineal wound dehiscence is defined as a score of 2 or 3 on the approximation item of the REEDA scale. A score of 2 indicates separated wound edges with the underlying tissues still in contact, and a score of 3 indicates separated wound edges with the underlying tissues not in contact.
Time frame: Day 21 postpartum, with an assessment window of ±3 days
Proportion of Participants Requiring Surgical Revision for Perineal Wound Dehiscence
The outcome is defined as any repeat surgical procedure performed because of dehiscence of the perineal tear or episiotomy wound.
Time frame: From vaginal birth through 12 weeks postpartum
Number of Participants With an Anaphylactic Reaction
An anaphylactic reaction is defined as acute mucocutaneous involvement occurring within minutes to hours and associated with respiratory compromise and/or arterial hypotension or related clinical signs, according to the protocol definition (safety outcome).
Time frame: From the study injection through 24 hours after the injection
Number of Participants Receiving Antibiotic Treatment for a Perineal Indication
This outcome is defined as the use of systemic or local antibiotic treatment prescribed for a suspected or confirmed infection involving the perineal tear or episiotomy wound (safety outcome).
Time frame: From the study injection through 24 weeks postpartum
Plan to share: Undecided — The sponsor has not yet approved a final plan for sharing de-identified individual participant data. This ClinicalTrials.gov record will be updated when a final decision has been made in accordance with applicable ethics, data protection, and institutional requirements.
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Studies of the drug tested here: Platelet rich plasma