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

NCT07727213 | Not Yet Recruiting

• 1 other identifier: 2026-00141 RELIEVE study
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Trauma; Postpartum Pain; Episiotomy; Perineal Laceration

Keywords

Platelet-rich plasma; PRP; Vaginal birth; Perineal tear; Perineal wound healing; Postpartum perineal pain; Dyspareunia; Sexual function; Genital self-image; Scar assessment

Outcome Measures

Primary Outcomes (1)

• Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum

  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.

  12 weeks postpartum, with an assessment window of ±2 weeks

Secondary Outcomes (14)

• 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

Other Outcomes (5)

• Proportion of Participants With Moderate or Severe Perineal Wound Dehiscence at 3 Months Postpartum

  12 weeks postpartum, with an assessment window of ±2 weeks

• Proportion of Participants With Moderate or Severe Perineal Wound Dehiscence at 3 Weeks Postpartum

  Day 21 postpartum, with an assessment window of ±3 days

• Proportion of Participants Requiring Surgical Revision for Perineal Wound Dehiscence

  From vaginal birth through 12 weeks postpartum

Study Arms (2)

Normal Saline

PLACEBO 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 Plasma

EXPERIMENTAL

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

Interventions

Autologous Non-Activated Platelet-Rich Plasma BIOLOGICAL

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.

Also known as: RegenPRP, RegenBCT-3, PRP

Autologous Platelet-Rich Plasma

Saline (0.9%, sterile, for infusion) DRUG

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.

Also known as: Normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University Hospitals of Geneva: collaborator
• Regen Lab SA: collaborator
• Fondation Ernst et Lucie Schmidheiny: collaborator

Study Sites (1)

University Hospital, Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Dyspareunia

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Océane Pécheux, Dr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Jasmine Abdulcadir, PD

  University Hospital, Geneva

  STUDY DIRECTOR

Central Study Contacts

Océane Pécheux, Dr

CONTACT

+41 79 553 50 95; oceane.pecheux@hug.ch

Ketty Hu, Dr

CONTACT

ketty.hu@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants will be randomised in a 1:1 ratio to receive either autologous non-activated platelet-rich plasma or 0.9% sodium chloride solution. Randomisation will be stratified by mode of vaginal birth, defined as spontaneous or operative vaginal birth, using randomly permuted block sizes of 2, 4, and 6.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

CH (1)