Effects of Perineal Massage, Vaginal Dilator and Pelvic Floor Muscles Training on the Perineal Integrity Primiparous: A Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Perineal Perineal integrity assessed by the absence or presence of perineal lacerations
研究概览
简要总结
Perineal trauma during childbirth is an important etiological factor of various undesirable complications to women's health, with emphasis on pelvic floor dysfunction. Thus, methods that preserve the perineal integrity have been a challenge to practices among health professionals working in the gravid-puerperal cycle assistance. Despite the remarkable importance of beneficial effects of pelvic floor preparation prior to vaginal birth on prevention of perineal trauma, there are few studies in the literature that point which is the best method to be used to reduce the chances of perineal lesions. Therefore, there is need for more studies to compare existing methods. The objective this present study is to compare the effects of perineal massage, the vaginal dilator and training of the muscles of the pelvic floor to prepare the pelvic floor for vaginal birth on perineal integrity of primiparous. Primigravidae women are selected over 18 years, from the 32th gestational week and wishing to have a vaginal birth. Women will be randomly allocated into 3 groups: perineal massage, vaginal dilator and pelvic floor muscles training and should practice the technique from the 34th week of pregnancy until the time of delivery. All the women will be subject to clinical evaluation, functional assessment of pelvic floor and perineal integrity assessment prior to the beginning of the practice of the technique and between 45 and 60 days after childbirth.
详细描述
METHODS:
Participants: Primigravidae women over 18 years old will be selected, from the 32th gestational week and wishing to have a vaginal delivery.
Interventions: Pregnant women will be randomly allocated into three groups: perineal massage, vaginal dilator and pelvic floor muscles training. The technique should be practiced from the 34th week of pregnancy until the beginning of labor. Randomization will be done by a researcher who was not involved with the recruitment, assessment and treatment of the participants. All participants will undergo a clinical and functional assessment of the pelvic floor before the beginning of the technique practice, as well as a reassessment of these items and an assessment of perineal integrity between 45 and 60 days after delivery for a blind physiotherapist regarding the interventional procedures.
Objective: To compare the effects of perineal massage, vaginal dilator and pelvic floor muscles training on the perineal integrity of primiparae women.
Outcome: The perineal integrity will be verified by the presence or absence of perineal laceration as well as their characteristics observed immediately after delivery.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •usual risk primigravidae women
- •primigravidae women from the 32nd gestational week
- •wishing to have a vaginal delivery
排除标准
- •pregnant women with pelvic or vaginal surgeries
- •presence of pelvic organ prolapse
- •intolerance to vaginal palpation
- •inability to contract the pelvic floor muscles
- •vaginal infections
- •neurological and/or cognitive impairments that prevent an understanding of the proposed procedures
- •pregnant women who used antenatal pelvic floor methods of preparation prior to study enrollment
研究组 & 干预措施
Perineal Massage
Massage is made in the perineum and vagina using your fingers to promote stretching of pelvic floor structures, making them more flexible and distensíveis, avoiding trauma during vaginal birth.
干预措施: Perineal massage (Other)
Vaginal Dilator
This device consists of a silicone balloon in an eight shape that, after inserted into the vagina, is inflated by manual pumping, promoting a stretching of the structures around it (hymenal edge, connective tissues and muscles perivaginal). This equipment assists the stretching of tissues around the vagina and the pelvic floor muscles, minimizing the risk of injury from the birth canal during the passage of the baby.
干预措施: Vaginal Dilator (Device)
Pelvic floor muscles training
Exercises emphasizing conscious muscle relaxation, i.e., considering a resting time based on the contraction time. The resting time was double of the sustaining time of each contraction up to the 38th week of pregnancy, after remaining fixed this relaxation time up to the moment of delivery. This time was chosen because during the expulsive labor phase, there is a need for the pelvic floor muscles to consciously relax during a long period, in order to facilitate the descendants and rotational movements of the baby's head and consequently, its passage. This exercises does not aim only muscle strength but also contraction promotion, which aims body and perineal awareness, muscle tone, coordination and appropriate motor control to allow an active muscle relaxation in the second labor stage.
干预措施: Pelvic floor muscles training (Other)
结局指标
主要结局
Perineal Perineal integrity assessed by the absence or presence of perineal lacerations
时间窗: This assessment will be done until 60 days after delivery
Perineal integrity assessed by the absence or presence of perineal lacerations as well as the description of its characteristics: type: classified as single or multiple considering the anterior and posterior perineum region and vaginal wall; Location: classified according to the affected region. Being the anterior region of the perineum, involving the clitoris, left little lip, small right lip, left vestibular region and right vestibular region. The posterior perineum region will be considered when involving left, right and middle region. The vaginal wall will be considered when it presents anterior, back, left back and right back lacerations; Degree of perineal laceration; Laceration form: It will be considered solely for the lacerations affecting posterior perineal region and should be classified as linear, branched and "U" shaped.
次要结局
- Function of the pelvic floor muscles evaluated by the PERFECT method(This assessment will be done at the time of initial evaluation (before the intervention) and between 45 and 60 days after delivery)
研究者
Priscila Godoy Januário Martins Alves
PhD student of the Postgraduate Program in Physical Therapy, Physical Therapy Department
Universidade Federal de Sao Carlos