Abstract / Summary
Abstract Background Perineal trauma, including perineal tears and episiotomy, is common after vaginal birth and may be followed by persistent pain, impaired wound healing, dyspareunia and altered genital self-image. Autologous platelet-rich plasma (PRP) concentrates platelets and locally releases mediators involved in inflammation, angiogenesis and tissue repair. Evidence supporting PRP during primary postpartum perineal repair remains insufficient. The RELIEVE trial will evaluate whether non-activated autologous PRP administered at the time of suturing reduces persistent perineal pain and improves multidimensional postpartum recovery. Methods RELIEVE is a single-centre, two-arm, parallel-group, superiority, triple-blind, placebo-controlled randomised trial at Geneva University Hospitals. We will recruit 160 women aged 18 years or older after vaginal birth with a second-degree or more severe perineal tear and/or episiotomy. Participants will be allocated 1:1, with stratification by spontaneous versus operative vaginal birth, to 4–5 mL of non-activated autologous PRP prepared with the RegenBCT-3 system or an identical-volume 0.9% saline injection. Approximately 0.1 mL will be injected at 5–10-mm intervals along both sides of the repaired lesion after closure of the deeper layers and before skin closure. The primary outcome is mean perineal pain during the previous seven days measured on a 0–100-mm visual analogue scale at 3 months postpartum. Secondary outcomes comprise pain at 3 weeks and 6 months; REEDA and POSAS 3.0 scores at 3 weeks and 3 months; and sexual function and genital self-image measured using the FSFI and FGSIS at 6 months. Safety outcomes, including perineal wound dehiscence, infection, injection-site haematoma, anaphylaxis, unplanned consultations for pain and surgical re-suturing, will be monitored and recorded throughout the follow-up period. The primary analysis will use intention-to-treat linear regression adjusted for prespecified prognostic variables. Discussion The placebo-controlled triple-blind design is intended to provide a robust, patient-centred assessment of PRP. The trial prioritises patient-reported outcomes reflecting pain, scar-related symptoms, sexual function and genital self-image. Multilingual procedures will support inclusion across diverse populations. Anticipated challenges include consent around an unpredictable birth, continuous intervention availability, training a large multidisciplinary team despite substantial staff turnover, and retention through 6 months. Trial registration ClinicalTrials.gov NCT07727213, 24 July 2026. SNCTP000007001 (HumRes68412).