Effects of Antenatal Pelvic Floor Preparation Techniques for Childbirth (EAPFPTC)

April 22, 2019 updated by: Priscila Godoy Januário Martins Alves, Universidade Federal de Sao Carlos

Effects of Perineal Massage, Vaginal Dilator and Pelvic Floor Muscles Training on the Perineal Integrity Primiparous: A Randomized Controlled Trial Protocol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Randomization: Participants randomization will be done from a sequence generated by a computer program.

Blinding: The evaluative procedures will be done by a 'blinded' physiotherapist in relation to the intervention procedures and the randomization procedure by a researcher who was not involved with the recruitment, evaluation and participant's treatment.

Discussion: The knowledge of the effects of antenatal pelvic floor preparation techniques on the perineal integrity and pelvic floor muscles function after delivery, will allow a better choice about which approach is the best to pregnant women to prevent perineal trauma.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13.565-905
        • Federal University of São Carlos - Physical therapy Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Perineal massage
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.
Other Names:
  • Perineal massage for prevention of perineal trauma
Active Comparator: 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.
Device: Vaginal Dilator
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.
Other Names:
  • Epi-No Vaginal Dilator
Active Comparator: 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.
Other: Pelvic floor muscles training
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.
Other Names:
  • Pelvic floor training for promotion of perineal integrity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perineal Perineal integrity assessed by the absence or presence of perineal lacerations
Time Frame: 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.
This assessment will be done until 60 days after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function of the pelvic floor muscles evaluated by the PERFECT method
Time Frame: This assessment will be done at the time of initial evaluation (before the intervention) and between 45 and 60 days after delivery
Function of the pelvic floor muscles evaluated by the PERFECT method between 45 and 60 days after delivery. This method is a functional assessment of the pelvic floor muscles allowing to analyze the muscle contraction and condition of the fibers. The contraction of pelvic floor muscles will be requested during expiration.
This assessment will be done at the time of initial evaluation (before the intervention) and between 45 and 60 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Priscila G Alves, Federal University of São Carlos - Physiotherapy Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2015

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAPESP #2015/02244-0
  • 1.218.385 (Other Identifier: Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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