RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy | NCT07727213

NCT07727213

Overview

NCT ID: NCT07727213
Lead Sponsor: University Hospital, GenevaOTHER
Official Title: 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.
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Jun 30, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 160Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts and Locations

Central Contacts: Océane Pécheux, DrContact
oceane.pecheux@hug.ch+41 79 553 50 95

Similar Studies

Participant Group/Arms

Normal SalinePlacebo Comparator

Participants will receive a single local perineal injection of 4-5 mL of 0.9% sodium chloride solution during primary repair of a second-degree or more severe perineal tear and/or episiotomy, after closure of the deeper layers and before skin closure.

Drug: Saline (0.9%, sterile, for infusion)

Autologous Platelet-Rich PlasmaExperimental

Participants will receive a single local perineal injection of 4-5 mL of autologous non-activated platelet-rich plasma during primary repair of a second-degree or more severe perineal tear and/or episiotomy, after closure of the deeper layers and before skin closure.

Biological: Autologous Non-Activated Platelet-Rich Plasma