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

ConditionsPerineal TraumaPostpartum PainEpisiotomyPerineal Laceration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous Non-Activated Platelet-Rich Plasma

    Biological/Vaccine

    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.

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Normal SalinePlacebo comparator 1 intervention
Group B: Autologous Platelet-Rich PlasmaExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Weeks 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.

Time frame
Day 21 postpartum, with an assessment window of ±3 days
2

Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 6 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.

Time frame
24 weeks postpartum, with an assessment window of ±2 weeks
3

Perineal Wound Healing Assessed by the REEDA Scale at 3 Weeks Postpartum

Perineal wound healing will be assessed using the Redness, Edema, Ecchymosis, Discharge, and Approximation scale. Each of the five items is scored from 0 to 3, giving a total score ranging from 0 to 15. Higher scores indicate poorer wound healing.

Time frame
Day 21 postpartum, with an assessment window of ±3 days
4

Perineal Wound Healing Assessed by the REEDA Scale at 3 Months Postpartum

Perineal wound healing will be assessed using the Redness, Edema, Ecchymosis, Discharge, and Approximation scale. Each of the five items is scored from 0 to 3, giving a total score ranging from 0 to 15. Higher scores indicate poorer wound healing.

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

Other outcomes

1

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

Moderate or severe perineal wound dehiscence is defined as a score of 2 or 3 on the approximation item of the REEDA scale. A score of 2 indicates separated wound edges with the underlying tissues still in contact, and a score of 3 indicates separated wound edges with the underlying tissues not in contact.

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

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

Moderate or severe perineal wound dehiscence is defined as a score of 2 or 3 on the approximation item of the REEDA scale. A score of 2 indicates separated wound edges with the underlying tissues still in contact, and a score of 3 indicates separated wound edges with the underlying tissues not in contact.

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

Proportion of Participants Requiring Surgical Revision for Perineal Wound Dehiscence

The outcome is defined as any repeat surgical procedure performed because of dehiscence of the perineal tear or episiotomy wound.

Time frame
From vaginal birth through 12 weeks postpartum
4

Number of Participants With an Anaphylactic Reaction

An anaphylactic reaction is defined as acute mucocutaneous involvement occurring within minutes to hours and associated with respiratory compromise and/or arterial hypotension or related clinical signs, according to the protocol definition (safety outcome).

Time frame
From the study injection through 24 hours after the injection

Sponsors and contacts

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University Hospital, Geneva

Lead sponsor

University Hospitals of Geneva

Collaborator

Regen Lab SA

Collaborator

Fondation Ernst et Lucie Schmidheiny

Collaborator

Source ClinicalTrials.gov

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