Effects of Antenatal Pelvic Floor Preparation Techniques for Childbirth

NCT02582580 | Completed

• 2 other identifiers: FAPESP #2015/02244-01.218.385
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

pelvic floor; perineal trauma; physiotherapy; perineal integrity

Outcome Measures

Primary Outcomes (1)

• Perineal Perineal integrity assessed by the absence or presence of perineal lacerations

  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.

  This assessment will be done until 60 days after delivery

Secondary Outcomes (1)

• 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

Study Arms (3)

Perineal Massage

ACTIVE COMPARATOR

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.

Other: Perineal massage

Vaginal Dilator

ACTIVE COMPARATOR

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.

Device: Vaginal Dilator

Pelvic floor muscles training

ACTIVE COMPARATOR

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.

Other: Pelvic floor muscles training

Interventions

Perineal massage OTHER

Perineal massage should be practiced once a day, from the 34th week of gestation until the beginning of labor. It should obey the following sequence: the pregnant woman must be positioned comfortably and use intimate water based lubricant at her fingertips; start the massage in the outdoor area of the vulva with circular movements of the skin and connective tissue around the vagina and at the central tendon of the perineum, clockwise, clitoris to clitoris; introduce two thumb fingers or index and middle fingers into the vagina at a distance of approximately 4 centimeters; perform internal massaging with laterally semicircles towards the anus for 20 to 30 seconds; put pressure down towards the anus and to each side of the vagina until feeling a slight burning or stretching sensation and hold the position for 2 minutes; massage the lower half of the vaginal introitus in a movement simulating the letter "U". All movements should be repeated four times.

Also known as: Perineal massage for prevention of perineal trauma

Perineal Massage

Vaginal Dilator DEVICE

Vaginal dilator Epi-No® should be used once a day for 15 minutes, from the 34th week of pregnancy until the beginning of labor. It should be coated with a condom and intimate water based lubricant and then be inserted into the vaginal canal in such way that the balloon stays two centimeters away from the vaginal introitus. The device will be inflated by manual pumping until the tolerable woman's limit. The pregnant woman will be encouraged to daily inflate a greater volume of compressed air into the balloon so that the amount of air is greater than the quantity in the previous day, achieving, day after day, a greater stretching of perivaginal structures, always respecting the individual tolerance limit. The amount of manual pumping imposed to inflate the balloon should be written in an Intervention Diary so that the next use, the pregnant woman will be sure that pumped the device more times than in the previous session.

Also known as: Epi-No Vaginal Dilator

Vaginal Dilator

Pelvic floor muscles training OTHER

Pregnant women allocated to this group will perform pelvic floor muscles training. The progression of the protocol of this study will occur gradually in view of the peculiarities that involve the pelvic floor in the gestational stage and the ultimate goal is the promotion of an intact perineum after vaginal delivery. The exercises will obey a sequence, according to the gestation week, considering the following factors/parameters: exercise position, number and sustaining period of slow and fast contractions, and relaxation time between contractions. All contractions should be during the expiratory phase of breathing associated with an isometric contraction of the abdominal muscles and at the end of each series of contractions, perform a one minute interval between sets and in that time perform the diaphragmatic breathing exercise to promote overall relaxation. This protocol should be practiced once a day, every day from the 34th week of gestation until the beginning of labor.

Also known as: Pelvic floor training for promotion of perineal integrity

Pelvic floor muscles training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• usual risk primigravidae women
• primigravidae women from the 32nd gestational week
• wishing to have a vaginal delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of São Carlos - Physical therapy Department

São Carlos, São Paulo, 13.565-905, Brazil

Location

Related Publications (42)

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Study Officials

• Priscila G Alves

  Federal University of São Carlos - Physiotherapy Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student of the Postgraduate Program in Physical Therapy, Physical Therapy Department

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 21, 2015
• Study Start: October 15, 2015
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

BR (1)