Perineal TraumaRELIEVENCT07727213
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
A study testing Autologous Non-Activated Platelet-Rich Plasma and Saline (0.9%, sterile, for infusion) in people with Perineal Trauma and Postpartum Pain, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Trauma, Postpartum Pain, Episiotomy
- What is being tested?
- Autologous Non-Activated Platelet-Rich Plasma and Saline (0.9%, sterile, for infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ketty Hu, Dr contact
Switzerland1 site
University Hospital, Geneva
Geneva, Canton of Geneva, 1205
Océane Pécheux, Dr, +41 79 553 50 95, oceane.pecheux@hug.ch
About this study
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.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Perineal Trauma, Postpartum Pain, Episiotomy, Perineal Laceration
- Being tested
- Autologous Non-Activated Platelet-Rich Plasma, Saline (0.9%, sterile, for infusion)
- Keywords
- Platelet-rich plasma, PRP, Vaginal birth, Perineal tear, Perineal wound healing, Postpartum perineal pain, Dyspareunia, Sexual function, Genital self-image, Scar assessment
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Non-Activated Platelet-Rich PlasmaBiological
Also called RegenPRP, RegenBCT-3, PRP
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
Also called Normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Autologous Non-Activated Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 24 weeks postpartum, with an assessment window of ±2 weeks
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.
Measured: Day 21 postpartum, with an assessment window of ±3 days
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.
Measured: 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
Scar quality will be assessed by a masked clinician using the 7-item Patient and Observer Scar Assessment Scale 3.0 Observer Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. The total score ranges from 7 to 35. Higher scores indicate poorer clinician-rated scar quality.
Measured: 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
Scar quality will be assessed by a masked clinician using the 7-item Patient and Observer Scar Assessment Scale 3.0 Observer Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. The total score ranges from 7 to 35. Higher scores indicate poorer clinician-rated scar quality.
Measured: 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
Participants will assess scar appearance, symptoms, and functional characteristics using the POSAS 3.0 Patient Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. Lower scores indicate better patient-rated scar quality. The score will be calculated according to the POSAS 3.0 scoring instructions.
Measured: 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
Participants will assess scar appearance, symptoms, and functional characteristics using the POSAS 3.0 Patient Scale. Each item is rated from 1, indicating no difference from normal skin, to 5, indicating an extreme difference from normal skin. Lower scores indicate better patient-rated scar quality. The score will be calculated according to the POSAS 3.0 scoring instructions.
Measured: 12 weeks postpartum, with an assessment window of ±2 weeks
Sexual Function Assessed by the Female Sexual Function Index
Sexual function during the preceding 4 weeks will be assessed using the 19-item Female Sexual Function Index. The instrument evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2 to 36, with higher scores indicating better sexual function. Participants may choose not to complete this sensitive questionnaire.
Measured: 24 weeks postpartum, with an assessment window of ±2 weeks
Sexual Pain Assessed by the Female Sexual Function Index Pain Domain
Pain and discomfort during or following vaginal penetration during the preceding 4 weeks will be assessed using the three-item pain domain of the Female Sexual Function Index. The domain score ranges from 0 to 6. Higher scores indicate less pain and better sexual function.
Measured: 24 weeks postpartum, with an assessment window of ±2 weeks
Genital Self-Image Assessed by the Female Genital Self-Image Scale
Genital self-image will be assessed using the 7-item Female Genital Self-Image Scale. Each item is rated from 1, strongly disagree, to 4, strongly agree. The total score ranges from 7 to 28, with higher scores indicating a more positive genital self-image.
Measured: 24 weeks postpartum, with an assessment window of ±2 weeks
Number of Participants With a Perineal Infection
Perineal infection will be identified from clinical findings, including purulent discharge or other protocol-defined signs of infection, perineal abscess, cellulitis, or another clinically diagnosed infection involving the perineal wound.
Measured: From the study injection through 24 weeks postpartum
Number of Participants With an Injection-Site Haematoma
Number of Participants With an Injection-Site Haematoma
Measured: Within 72 hours after vaginal birth
Number of Participants With a Serious Adverse Event
Serious adverse events will be defined according to International Council for Harmonisation criteria and will include events resulting in death, being life-threatening, requiring or prolonging hospitalisation, causing persistent or significant disability, or constituting another important medical event (safety outcome).
Measured: From the study injection through 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Geneva, Regen Lab SA, Fondation Ernst et Lucie Schmidheiny
- Responsible party
- Principal investigator, Océane Pécheux, University Hospital, Geneva
- Investigators
- Océane Pécheux, Dr, Principal investigator, University Hospital, GenevaJasmine Abdulcadir, PD, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727213
- Sponsor's protocol ID
- 2026-00141 RELIEVE study
- Acronym
- RELIEVE
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sponsor has not yet approved a final plan for sharing de-identified individual participant data. This ClinicalTrials.gov record will be updated when a final decision has been made in accordance with applicable ethics, data protection, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07727213
- Acronym / sponsor ID
- RELIEVE / 2026-00141 RELIEVE study
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University Hospitals of Geneva, Regen Lab SA, Fondation Ernst et Lucie Schmidheiny
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Saline (0.9%, sterile, for infusion)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. |
| Autologous Platelet-Rich Plasma | Experimental | Biological: Autologous Non-Activated Platelet-Rich PlasmaParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Non-Activated Platelet-Rich PlasmaAlso: RegenPRP, RegenBCT-3, PRPAutologous 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. | Biological | Autologous Platelet-Rich Plasma |
| Saline (0.9%, sterile, for infusion)Also: Normal salineApproximately 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. | Drug | Normal Saline |
Primary outcome
Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum
Time frame: 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.
14 secondary outcomes
Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Weeks Postpartum
Time frame: 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
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Perineal Wound Healing Assessed by the REEDA Scale at 3 Weeks Postpartum
Time frame: Day 21 postpartum, with an assessment window of ±3 days
Perineal Wound Healing Assessed by the REEDA Scale at 3 Months Postpartum
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks postpartum, with an assessment window of ±2 weeks
Sexual Function Assessed by the Female Sexual Function Index
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Sexual Pain Assessed by the Female Sexual Function Index Pain Domain
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Genital Self-Image Assessed by the Female Genital Self-Image Scale
Time frame: 24 weeks postpartum, with an assessment window of ±2 weeks
Number of Participants With a Perineal Infection
Time frame: From the study injection through 24 weeks postpartum
Number of Participants With an Injection-Site Haematoma
Time frame: Within 72 hours after vaginal birth
Number of Participants With a Serious Adverse Event
Time frame: From the study injection through 24 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided. The sponsor has not yet approved a final plan for sharing de-identified individual participant data. This ClinicalTrials.gov record will be updated when a final decision has been made in accordance with applicable ethics, data protection, and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ketty Hu, Dr contact
Océane Pécheux, Dr principal investigator
University Hospital, Geneva
Jasmine Abdulcadir, PD study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Non-Activated Platelet-Rich Plasma and Saline (0.9%, sterile, for infusion) in people with Perineal Trauma and Postpartum Pain, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Océane Pécheux, Dr (+41 79 553 50 95, oceane.pecheux@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal Pain Intensity Assessed by a 100-mm Visual Analogue Scale at 3 Months Postpartum (time frame: 12 weeks postpartum, with an assessment window of ±2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.