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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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11 June 2018 |
Main ID: |
ACTRN12617000437369 |
Date of registration:
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24/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effects of lateral episiotomy on the function of pelvic floor and sexual function after vaginal delivery in primiparas
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Scientific title:
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Effects of lateral episiotomy on the function of pelvic floor and sexual function after vaginal delivery in primiparas |
Date of first enrolment:
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15/02/2016 |
Target sample size:
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200 |
Recruitment status: |
Completed |
URL:
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http://www.anzctr.org.au/ACTRN12617000437369.aspx |
Study type:
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Observational |
Study design:
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Phase:
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Pelvic floor dysfunction post vaginal delivery.
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Intervention(s)
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Episiotomy is an obstetric procedure during which the surgical incision extends the vestibule of the vagina during the second stage of labor. A lateral episiotomy cut starts 1-2 cm from the posterior fourchette in the direction of the tuberosity of the ischium (tuberositas ossis ischii). The lateral episiotomy is often used in modern obstetric practice, although it is rarely mentioned in the literature. The aim of this research is to investigate the effect of lateral episiotomy on the pelvic floor and the possible occurrence of incontinence of urine and stool, and sexual dysfunction in primiparas compared with a group of women without episiotomy. The study design is a prospective cohort study. Pregnant women will be divided into two groups. The first group consists of pregnant women who were delivered with lateral episiotomy, another group that were delivered with an intact perineum or had the perineal rupture of the first and the second degree. The study will include primiparas with singleton pregnancies and spontaneous beginning of labor. Examinees who choose to participate in the study will give their consent to participate in the study by signing an informed consent. Exclusion criteria are birth by Caesarean section, perineal rupture of the third and the fourth degree, preterm delivery, breech presentation, instrumental delivery, pluriparity, the pre-existent anal and urinary incontinence before delivery, fetal head deflextion, fetal head malposition, pre-existing dyspareunia, urinary incontinence and fecal incontinence during pregnancy, and family medical history in terms of pelvic floor dysfunction and any pelvic surgery before pregnancy. Control inspections of function of pelvic floor will be at five and eight months after vaginal delivery. Each patient will fill in questionnaires which will assess the possible disturbance of urine and fecal continence and of sexual dysfunction. We will use the "International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form" (ICIQ-UI-SF) to assess the degree of urinary incontinence. For the evaluation of fecal incontinence, "Wexner Continence Grading Scale" will be used. Assessment of sexual function will be assessed with "Female Sexual Function Index" (FSFI). Then we will make the clinical assessment of pelvic floor function, which will include: quantification by POP-Q (Pelvic Organ Prolapse Quantification System) system, clinical tests for assesing stress urinary incontinence (Bonney test, Q-tip test), transperineal/vaginal sonography for assessing the functional anatomy of the anal sphincter complex and the muscle levator ani and assessment of the strength of pelvic floor muscles by vaginal perineometry. This research is supposed to include 200 respondents, or 100 respondents per group.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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