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

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.

Conditions

• Perineal Trauma
• Postpartum Pain
• Episiotomy
• Perineal Laceration

Interventions

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.

DRUG

Saline (0.9%, sterile, for infusion)

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 & Collaborators

• University Hospitals of Geneva

  collaborator UNKNOWN

• Regen Lab SA

  collaborator INDUSTRY

• Fondation Ernst et Lucie Schmidheiny

  collaborator UNKNOWN

• University Hospital, Geneva

  lead OTHER

Principal Investigators

• Océane Pécheux, Dr · University Hospital, Geneva

• Jasmine Abdulcadir, PD · University Hospital, Geneva

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2028-06-30

Completion

2028-08-31

Countries

• Switzerland

Study Locations