Clinical Trial

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

Study acronym: RELIEVE
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07727213
Lead Sponsor University Hospital, Geneva
Collaborators: University Hospitals of Geneva, Regen Lab SA, Fondation Ernst et Lucie Schmidheiny
Conditions Perineal Trauma, Postpartum Pain, Episiotomy, Perineal Laceration
Enrollment 160 participants
Start Date 2026-10-01
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-27