跳至主要内容
临床试验/NCT06443736
NCT06443736招募中不适用

Antenatal ThREe Steps Perineal mASSage in Reducing Perineal Trauma and Post-partum Morbidities: TRESPASS Clinical Study

Azienda Sanitaria-Universitaria Integrata di Udine2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
154
试验地点
2
主要终点
Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups

研究概览

简要总结

The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Rate of intact perineum and perineal tears (classified on the basis of RCOG classification) in the two groups

时间窗: 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).

次要结局

  • Change from the baseline in perineal pain in postpartum using the Numeric Pain Rating Scale (0-10).(At 7-14-21 days postpartum)
  • Duration of the second stage of labor in the two groups(At the delivery)
  • Rate of operative delivery and episiotomies in the two groups(During labor and delivery)
  • Change from the baseline in perineal pain in postpartum using the Pelvic Pain Impact Questionnaire(at 45 +/-5 days postpartum.)
  • Change from the baseline in dyspareunia in postpartum using the Marinoff Dyspareunia Scale(At 45 +/-5 days postpartum.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martina Arcieri

Principal Investigator, Medical Doctor

Azienda Sanitaria-Universitaria Integrata di Udine

研究点 (2)

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