Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443736
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-27
Brief Title:
TRESPASS Clinical Study
Sponsor:
Azienda Sanitaria-Universitaria Integrata di Udine
Organization:
Azienda Sanitaria-Universitaria Integrata di Udine
Study Overview
Official Title:
Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities TRESPASS Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 womens 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None