An interventional study of Standardized perineal massage and Primary prevention in Perineal Laceration, Tear, or Rupture During Delivery, sponsored by Azienda Sanitaria-Universitaria Integrata di Udine. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Azienda Sanitaria-Universitaria Integrata di Udine · Not applicable, Interventional, and Prevention
The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 154 is above the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Azienda Sanitaria-Universitaria Integrata di Udine is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Standardized perineal massage
Behavioral: Primary prevention
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.
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.
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).
Time frame: At the delivery
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 45 +/-5 days postpartum.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Sanitaria-Universitaria Integrata di Udine