Perineal Laceration, Tear, or Rupture During DeliveryNCT06443736
TRESPASS Clinical Study
A study testing Standardized perineal massage and Primary prevention in people with Perineal Laceration, Tear, or Rupture During Delivery, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial summary
The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Laceration, Tear, or Rupture During Delivery
- What is being tested?
- Standardized perineal massage and Primary prevention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- 19 Apr 2024to 19 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single pregnancy
- Part presented cephalic
- Age between 18 and 40 years
- Pregravid body mass index (BMI) between 18 and 29.9
- Understanding of the Italian language
- Estimated Fetal Weight in range (3rdcentile to 97thcentile according to Intergrowth)
Who cannot join
- Multipara
- Age < 18 years and age > 40 years
- Presence of pre-pregnancy bladder-sphincter-perineal disorders
- Medical contraindications to vaginal delivery
- Birth occurred by cesarean section
- Pregravid BMI > 30
Show all 12Show fewer
- Estimated Fetal Weight < 3rdcentile (Small for Gestational Age/Intrauterine Growth Restriction fetus) or > 97thcentile (> 4500 g) according to Intergrowth
- Fetal weight at birth > 4500 g
- Twin pregnancy
- Preterm delivery (< 37 weeks gestation)
- Personal history of connective tissue disease
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine
Udine, 33100
Lorenza Driul
Martina Arcieri
About this study
Official title: Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study
The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.
Read the detailed description
Perineal trauma from delivery correlates with an increased incidence of perineal pain and discomfort, dyspareunia and sexual dysfunction, as well as urinary and anal incontinence and therefore have a significant impact on women's physical and mental health. Prepartum perineal massage has been shown to reduce the incidence of spontaneous vagino-perineal tears and promote better anatomo-functional recovery of the perineum in the postpartum period. To date, there are no guidelines on the best modes of perineal massage, and there is a lack of true standardization of the process in the literature. The authors developed, on the basis of the evidence available at the present time, a peculiar type of perineal massage, embedded in a standardized clinical process including training and follow-up of the patient. All pregnant patients who meet the inclusion criteria will be selected and offered participation in the study by delivering the information brochure at the 2nd trimester obstetrical visit. If at the 3rd trimester obstetrical visit the patient expresses willingness to participate in the study, consent will be signed and enrollment and randomization to the study will be performed. The patient will then be notified of the date of the training meeting held by the investigator and/or co-authors; at this meeting, a brief lecture on aspects of primary pelvic floor prevention will be offered to patients in group A, who will also be educated on the perineal massage proposed by the Authors. Group B patients will equally be offered a short lecture on aspects of primary prevention, leaving the patient free choice in pelvic floor education in pregnancy. Group A patients will perform the learned perineal massage at home, reporting their adherence to the study in a diary. After delivery, at the time of discharge, a data collection form regarding postpartum perineal pain will be given to the patient and the date of the 45-day follow-up visit will be communicated. Thus, the primary endpoint of the present study is to assess the difference in incidence in the two study groups of the absence of vagino-perineal tears (intact perineum). Secondary endpoints to be assessed are the superiority of perineal massage on the duration of the second stage of labor, on incidence of operative delivery and episiotomies, and on perineal pain and dyspareunia in postpartum. Investigating the relationship between prepartum perineal massage and perineal tears (and related short- and long-term morbidity) could lead to improvement in obstetric clinical practice by giving the right guidance to the pregnant woman in pelvic floor education.
- Being tested
- Standardized perineal massage, Primary prevention
- Keywords
- Perineal Laceration, Perineal Trauma, Vaginal delivery, Perineal massage, Operative vaginal birth
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized perineal massageProcedure or surgery
Patients in this arm will be educated in the perineal massage proposed by the authors; the training will be performed during a group session, (organized bimonthly) conducted by obstetrical staff specialists, in the presence of the principal investigator and/or co-authors. In these sessions, a brief lecture on aspects of primary prevention related to pelvic floor structures (healthy diet, body weight control, moderate physical activity avoiding excessive exertion, posture control, therapy minctional education) and then screened an explanatory video regarding the three-step perineal massage proposed by the authors. The adequately prepared patient should then apply such perineal massage at home from the 34th gestational week until delivery according to the procedural methods provided.
Primary preventionBehavioural
Patients in this arm will be offered a group meeting in which aspects of primary prevention related to the structures of the pelvic floor (healthy diet, body weight control, moderate physical activity avoiding exertion excessive exertion, posture control, micturition educational therapy); participation in this meeting will be on a voluntary basis, and patients randomized to that group will have free choice in educating the pelvic floor pelvic floor in pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Standardized perineal massage | Experimental | Not described Receives: Procedure: Standardized perineal massage |
| Standard prevention | Active comparator | Not described Receives: Behavioral: Primary prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups
The degree of perineal tears will be assessed at the delivery by using the classification system for perineal tears recommended by the Royal College of Obstetricians and Gynaecologists (RCOG classification).
Measured: At the delivery
Secondary outcomes (5)
Duration of the second stage of labor in the two groups
Second stage describes the period of time from complete cervical dilation to 10 centimeters to the delivery of the neonate. It will be assessed in minutes.
Measured: At the delivery
Rate of operative delivery and episiotomies in the two groups
It will be assessed considering the number of participants in each group receiving operative delivery or episiotomy
Measured: During labor and delivery
Change from the baseline in perineal pain in postpartum using the Numeric Pain Rating Scale (0-10).
After delivery, at the time of discharge, the patient will be given a data collection form regarding postpartum perineal pain using NRS scale to be completed at 7-14-21 days after delivery and will be told the date of the follow-up visit at 45 days.
Measured: At 7-14-21 days postpartum
Change from the baseline in perineal pain in postpartum using the Pelvic Pain Impact Questionnaire
During the follow-up visit at 45 days, a general evaluation of the external and internal genitalia and pelvic floor (PC test) and swab test for perineal pain assessment will be performed on that occasion; the on-site completion of the Pelvic Pain Impact Questionnaire to assess the impact of perineal pain on quality of life will also be requested.
Measured: at 45 +/-5 days postpartum.
Change from the baseline in dyspareunia in postpartum using the Marinoff Dyspareunia Scale
During the follow-up visit 45 days after delivery, the Marinoff Dyspareunia Scale questionnaire for the assessment of dyspareunia in postpartum women who have resumed sexual intercourse will be requested to be completed on site.
Measured: At 45 +/-5 days postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start19 Apr 2024
- Primary completion19 Apr 2025 (estimated)
- Study completion19 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal Laceration, Tear, or Rupture During DeliveryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Arcieri, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443736
- Sponsor's protocol ID
- 17506
- Status last verified
- May 2024
- First submitted
- 27 Apr 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study
- ClinicalTrials.gov ID
- NCT06443736
- Acronym / sponsor ID
- 17506
- Keywords
- Perineal Laceration, Perineal Trauma, Vaginal delivery, Perineal massage, Operative vaginal birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 19 Apr 2025 (estimated)
- Study completion
- 19 Apr 2026 (estimated)
- First posted
- 5 Jun 2024 (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.
The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.
Detailed description
Perineal trauma from delivery correlates with an increased incidence of perineal pain and discomfort, dyspareunia and sexual dysfunction, as well as urinary and anal incontinence and therefore have a significant impact on women's physical and mental health. Prepartum perineal massage has been shown to reduce the incidence of spontaneous vagino-perineal tears and promote better anatomo-functional recovery of the perineum in the postpartum period. To date, there are no guidelines on the best modes of perineal massage, and there is a lack of true standardization of the process in the literature. The authors developed, on the basis of the evidence available at the present time, a peculiar type of perineal massage, embedded in a standardized clinical process including training and follow-up of the patient. All pregnant patients who meet the inclusion criteria will be selected and offered participation in the study by delivering the information brochure at the 2nd trimester obstetrical visit. If at the 3rd trimester obstetrical visit the patient expresses willingness to participate in the study, consent will be signed and enrollment and randomization to the study will be performed. The patient will then be notified of the date of the training meeting held by the investigator and/or co-authors; at this meeting, a brief lecture on aspects of primary pelvic floor prevention will be offered to patients in group A, who will also be educated on the perineal massage proposed by the Authors. Group B patients will equally be offered a short lecture on aspects of primary prevention, leaving the patient free choice in pelvic floor education in pregnancy. Group A patients will perform the learned perineal massage at home, reporting their adherence to the study in a diary. After delivery, at the time of discharge, a data collection form regarding postpartum perineal pain will be given to the patient and the date of the 45-day follow-up visit will be communicated. Thus, the primary endpoint of the present study is to assess the difference in incidence in the two study groups of the absence of vagino-perineal tears (intact perineum). Secondary endpoints to be assessed are the superiority of perineal massage on the duration of the second stage of labor, on incidence of operative delivery and episiotomies, and on perineal pain and dyspareunia in postpartum. Investigating the relationship between prepartum perineal massage and perineal tears (and related short- and long-term morbidity) could lead to improvement in obstetric clinical practice by giving the right guidance to the pregnant woman in pelvic floor education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized perineal massage | Experimental | Procedure: Standardized perineal massage |
| Standard prevention | Active comparator | Behavioral: Primary prevention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Single pregnancy
- Part presented cephalic
- Age between 18 and 40 years
- Pregravid body mass index (BMI) between 18 and 29.9
- Understanding of the Italian language
Key exclusion criteria (12 listed)
- Multipara
- Age < 18 years and age > 40 years
- Presence of pre-pregnancy bladder-sphincter-perineal disorders
- Medical contraindications to vaginal delivery
- Birth occurred by cesarean section
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 |
|---|---|---|
| Standardized perineal massagePatients in this arm will be educated in the perineal massage proposed by the authors; the training will be performed during a group session, (organized bimonthly) conducted by obstetrical staff specialists, in the presence of the principal investigator and/or co-authors. In these sessions, a brief lecture on aspects of primary prevention related to pelvic floor structures (healthy diet, body weight control, moderate physical activity avoiding excessive exertion, posture control, therapy minctional education) and then screened an explanatory video regarding the three-step perineal massage proposed by the authors. The adequately prepared patient should then apply such perineal massage at home from the 34th gestational week until delivery according to the procedural methods provided. | Procedure or surgery | Standardized perineal massage |
| Primary preventionPatients in this arm will be offered a group meeting in which aspects of primary prevention related to the structures of the pelvic floor (healthy diet, body weight control, moderate physical activity avoiding exertion excessive exertion, posture control, micturition educational therapy); participation in this meeting will be on a voluntary basis, and patients randomized to that group will have free choice in educating the pelvic floor pelvic floor in pregnancy. | Behavioural | Standard prevention |
Primary outcome
Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups
Time frame: At the delivery
The degree of perineal tears will be assessed at the delivery by using the classification system for perineal tears recommended by the Royal College of Obstetricians and Gynaecologists (RCOG classification).
5 secondary outcomes
Duration of the second stage of labor in the two groups
Time frame: At the delivery
Rate of operative delivery and episiotomies in the two groups
Time frame: During labor and delivery
Change from the baseline in perineal pain in postpartum using the Numeric Pain Rating Scale (0-10).
Time frame: At 7-14-21 days postpartum
Change from the baseline in perineal pain in postpartum using the Pelvic Pain Impact Questionnaire
Time frame: at 45 +/-5 days postpartum.
Change from the baseline in dyspareunia in postpartum using the Marinoff Dyspareunia Scale
Time frame: At 45 +/-5 days postpartum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized perineal massage and Primary prevention in people with Perineal Laceration, Tear, or Rupture During Delivery, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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 Italy. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Arcieri (+00393478114704, martina.arcieri@asufc.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups (time frame: At the delivery). 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 5 Jun 2024.