Perineal Trauma, Postpartum Pain, Episiotomy, Perineal Laceration
Conditions
Keywords
Platelet-rich plasma, PRP, Vaginal birth, Perineal tear, Perineal wound healing, Postpartum perineal pain, Dyspareunia, Sexual function, Genital self-image, Scar assessment
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAutologous 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.
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.
Sponsors
University Hospital, Geneva
University Hospitals of Geneva
Regen Lab SA
Fondation Ernst et Lucie Schmidheiny
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, the clinician administering the study injection, the clinicians performing the postpartum outcome assessments, and the statistician/data analyst will be masked to treatment allocation. A designated unmasked study team member will perform randomisation and prepare the assigned syringe. This person will not administer the intervention, conduct follow-up assessments, or participate in outcome analysis. The syringe will be covered to conceal the colour and appearance of its contents before being handed to the masked injecting clinician.
Intervention model description
Participants will be randomised in a 1:1 ratio to receive either autologous non-activated platelet-rich plasma or 0.9% sodium chloride solution. Randomisation will be stratified by mode of vaginal birth, defined as spontaneous or operative vaginal birth, using randomly permuted block sizes of 2, 4, and 6.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum | 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
| Measure | Time frame | Description |
|---|---|---|
| Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Weeks Postpartum | 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. |
| Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 6 Months Postpartum | 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. |
| Perineal Wound Healing Assessed by the REEDA Scale at 3 Weeks Postpartum | 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. |
| Perineal Wound Healing Assessed by the REEDA Scale at 3 Months Postpartum | 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. |
| Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Weeks Postpartum | 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. |
| Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Months Postpartum | 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. |
| Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Weeks Postpartum | 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. |
| Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Months Postpartum | 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. |
| Sexual Function Assessed by the Female Sexual Function Index | 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. |
| Sexual Pain Assessed by the Female Sexual Function Index Pain Domain | 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. |
| Genital Self-Image Assessed by the Female Genital Self-Image Scale | 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. |
| Number of Participants With a Perineal Infection | 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. |
| Number of Participants With an Injection-Site Haematoma | Within 72 hours after vaginal birth | Number of Participants With an Injection-Site Haematoma |
| Number of Participants With a Serious Adverse Event | 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). |
Countries
Switzerland
Contacts
CONTACTOcéane Pécheux, Dr
CONTACTKetty Hu, Dr
PRINCIPAL_INVESTIGATOROcéane Pécheux, Dr
University Hospital, Geneva
STUDY_DIRECTORJasmine Abdulcadir, PD
University Hospital, Geneva
Outcome results
None listed