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NCT Number: NCT07727213

RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy

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.

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Key information

Conditions

Perineal Trauma Dyspareunia Episiotomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Perineal Laceration Postpartum Pain Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Vaginal birth with a second-degree or more severe perineal tear and/or an episiotomy
  • Written informed consent obtained before any study-specific procedure

Exclusion criteria

  • Refusal to participate or lack of decision-making capacity at the time of consent
  • Inability to ensure an adequately informed consent process despite appropriate support measures, including adapted oral information and, when required, faithful translation or assistance from a professional interpreter
  • Clinically significant hereditary or acquired coagulation disorder, including platelet count below 100 × 10^9/L, international normalized ratio above 1.5, activated partial thromboplastin time above 1.5 times the upper limit of normal, congenital coagulation factor deficiency, von Willebrand disease, or prophylactic or therapeutic anticoagulation administered less than 24 hours before venous blood sampling for PRP preparation
  • Aspirin or clopidogrel taken within 7 days before venous blood sampling for PRP preparation
  • Previous enrolment in the RELIEVE study

Treatment and study plan

Autologous Non-Activated Platelet-Rich Plasma

Biological

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.

Other names: RegenPRP, RegenBCT-3, PRP

Saline (0.9%, sterile, for infusion)

Drug

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.

Other names: Normal saline

Primary outcomes

  1. Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum

    Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks

    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.

Secondary outcomes

  1. Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Weeks Postpartum

    Time frame: Day 21 postpartum, with an assessment window of ±3 days

    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.

  2. Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 6 Months Postpartum

    Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks

    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.

  3. Perineal Wound Healing Assessed by the REEDA Scale at 3 Weeks Postpartum

    Time frame: Day 21 postpartum, with an assessment window of ±3 days

    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.

  4. Perineal Wound Healing Assessed by the REEDA Scale at 3 Months Postpartum

    Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks

    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.

  5. Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Weeks Postpartum

    Time frame: Day 21 postpartum, with an assessment window of ±3 days

    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.

  6. Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Months Postpartum

    Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks

    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.

  7. Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Weeks Postpartum

    Time frame: Day 21 postpartum, with an assessment window of ±3 days

    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.

  8. Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Months Postpartum

    Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks

    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.

  9. Sexual Function Assessed by the Female Sexual Function Index

    Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks

    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.

  10. Sexual Pain Assessed by the Female Sexual Function Index Pain Domain

    Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks

    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.

  11. Genital Self-Image Assessed by the Female Genital Self-Image Scale

    Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks

    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.

  12. Number of Participants With a Perineal Infection

    Time frame: From the study injection through 24 weeks postpartum

    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.

  13. Number of Participants With an Injection-Site Haematoma

    Time frame: Within 72 hours after vaginal birth

    Number of Participants With an Injection-Site Haematoma

  14. Number of Participants With a Serious Adverse Event

    Time frame: From the study injection through 24 weeks postpartum

    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).

Other outcomes

  1. Proportion of Participants With Moderate or Severe Perineal Wound Dehiscence at 3 Months Postpartum

    Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks

    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.

  2. Proportion of Participants With Moderate or Severe Perineal Wound Dehiscence at 3 Weeks Postpartum

    Time frame: Day 21 postpartum, with an assessment window of ±3 days

    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.

  3. Proportion of Participants Requiring Surgical Revision for Perineal Wound Dehiscence

    Time frame: From vaginal birth through 12 weeks postpartum

    The outcome is defined as any repeat surgical procedure performed because of dehiscence of the perineal tear or episiotomy wound.

  4. Number of Participants With an Anaphylactic Reaction

    Time frame: From the study injection through 24 hours after the injection

    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).

  5. Number of Participants Receiving Antibiotic Treatment for a Perineal Indication

    Time frame: From the study injection through 24 weeks postpartum

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ketty Hu, Dr

CONTACT

[email protected]

Océane Pécheux, Dr

CONTACT

[email protected]

+41 79 553 50 95

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Fondation Ernst et Lucie Schmidheiny
  • Regen Lab SA
  • University Hospitals of Geneva

Registry information

Official study title

RELIEVE Study (REducing Labour-Induced Episiotomy and Vaginal Tear Pain Using Platelet Rich Plasma (PRP) for Enhanced Healing): A Triple-blind, Randomised, Placebo-controlled Trial Assessing PRP for Reducing Postpartum Pain After Perineal Tears or Episiotomies.

Acronym: RELIEVE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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