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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum
时间窗: 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.
次要结局
- 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)
- 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)
- 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 Assessed by the REEDA Scale at 3 Months Postpartum(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(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(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(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(12 weeks postpartum, with an assessment window of ±2 weeks)
- Sexual Function Assessed by the Female Sexual Function Index(24 weeks postpartum, with an assessment window of ±2 weeks)
- Sexual Pain Assessed by the Female Sexual Function Index Pain Domain(24 weeks postpartum, with an assessment window of ±2 weeks)
- Genital Self-Image Assessed by the Female Genital Self-Image Scale(24 weeks postpartum, with an assessment window of ±2 weeks)
- Number of Participants With a Perineal Infection(From the study injection through 24 weeks postpartum)
- Number of Participants With an Injection-Site Haematoma(Within 72 hours after vaginal birth)
- Number of Participants With a Serious Adverse Event(From the study injection through 24 weeks postpartum)
研究者
Océane Pécheux
Principal investigator
University Hospital, Geneva