Standardized perineal massage to reduce delivery-related lacerations
Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study
This study tests if teaching pregnant women a specific massage technique can help reduce tears during delivery and improve recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Azienda Sanitaria-Universitaria Integrata di Udine Academic / other |
| Locations | 1 site (Udine) |
| Trial ID | NCT06443736 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the effectiveness of a standardized perineal massage technique in reducing the incidence of vagino-perineal lacerations during delivery. The study involves training pregnant patients on this massage technique, which is believed to promote better recovery and reduce complications such as pain and incontinence. Participants will be recruited during their second trimester and will receive education and follow-up throughout the process. The study seeks to establish a standardized approach to perineal massage, addressing a gap in current clinical guidelines.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 40 with a single, cephalic-presenting fetus and a pregravid BMI between 18 and 29.9.
Not a fit: Patients who may not benefit include those with multiple pregnancies, pre-existing perineal disorders, or those who do not meet the specified age and BMI criteria.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of perineal lacerations and improve postpartum recovery for women.
How similar studies have performed: While there is limited standardization in perineal massage techniques, previous studies have indicated that perineal massage can reduce the incidence of tears, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
Where this trial is running
Udine
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine — Udine, Italy (Recruiting)
Study contacts
- Study coordinator: Martina Arcieri
- Email: martina.arcieri@asufc.sanita.fvg.it
- Phone: +00393478114704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.