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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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 ski
• Препарат 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.

Первичные конечные точки

• Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum [Срок оценки: 12 weeks postpartum, with an assessment window of ±2 weeks]

Вторичные конечные точки (12)

• Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Weeks Postpartum [Срок оценки: Day 21 postpartum, with an assessment window of ±3 days]
• Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 6 Months Postpartum [Срок оценки: 24 weeks postpartum, with an assessment window of ±2 weeks]
• Perineal Wound Healing Assessed by the REEDA Scale at 3 Weeks Postpartum [Срок оценки: Day 21 postpartum, with an assessment window of ±3 days]
• Perineal Wound Healing Assessed by the REEDA Scale at 3 Months Postpartum [Срок оценки: 12 weeks postpartum, with an assessment window of ±2 weeks]
• Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Weeks Postpartum [Срок оценки: Day 21 postpartum, with an assessment window of ±3 days]
• Clinician-Rated Scar Quality Assessed by the POSAS 3.0 Observer Scale at 3 Months Postpartum [Срок оценки: 12 weeks postpartum, with an assessment window of ±2 weeks]
• Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Weeks Postpartum [Срок оценки: Day 21 postpartum, with an assessment window of ±3 days]
• Patient-Rated Scar Quality Assessed by the POSAS 3.0 Patient Scale at 3 Months Postpartum [Срок оценки: 12 weeks postpartum, with an assessment window of ±2 weeks]
• Sexual Function Assessed by the Female Sexual Function Index [Срок оценки: 24 weeks postpartum, with an assessment window of ±2 weeks]
• Sexual Pain Assessed by the Female Sexual Function Index Pain Domain [Срок оценки: 24 weeks postpartum, with an assessment window of ±2 weeks]
• Genital Self-Image Assessed by the Female Genital Self-Image Scale [Срок оценки: 24 weeks postpartum, with an assessment window of ±2 weeks]
• Number of Participants With a Perineal Infection [Срок оценки: From the study injection through 24 weeks postpartum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital, Geneva — Geneva

Идентификаторы

NCT: NCT07727213 · 2026-00141 RELIEVE study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗