Effects of Antenatal Pelvic Floor Preparation Techniques for Childbirth

NCT02582580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-04-23

No results posted yet for this study

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

Interventions

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.

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

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.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV
  • Universidade Federal de Sao Carlos

    lead OTHER

Principal Investigators

  • Priscila G Alves · Federal University of São Carlos - Physiotherapy Department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2017-08-30
Completion
2017-08-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582580 on ClinicalTrials.gov