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Trial registered on ANZCTR
Registration number
ACTRN12617000437369
Ethics application status
Approved
Date submitted
21/11/2016
Date registered
24/03/2017
Date last updated
12/03/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of lateral episiotomy on the function of pelvic floor and sexual function after vaginal delivery in primiparas
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Scientific title
Effects of lateral episiotomy on the function of pelvic floor and sexual function after vaginal delivery in primiparas
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Secondary ID [1]
290587
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pelvic floor dysfunction post vaginal delivery.
301047
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Condition category
Condition code
Reproductive Health and Childbirth
300836
300836
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0
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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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Intervention code [1]
296450
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Not applicable
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Comparator / control treatment
Group of women who were delivered with an intact perineum or had the perineal rupture of the first and the second degree.
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Control group
Active
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Outcomes
Primary outcome [1]
300252
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To investigate duration of second stage of labor on the basis of data collected from medical records.
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Assessment method [1]
300252
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Timepoint [1]
300252
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5 months after vaginal delivery.
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Primary outcome [2]
300253
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To estimate strength and morphology of pelvic floor muscles. This outcome will be assessed by perineometer, expressed in mmH2O unit and by ultrasound scan and is composite outcome.
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Assessment method [2]
300253
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Timepoint [2]
300253
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5 months after vaginal delivery.
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Primary outcome [3]
300560
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To investigate pelvic organ prolapse.and incidence of stress urinary incontinence.
This will be assessed by “International Consultation on Incontinence Questionnaire - Short Form” (ICIQ-SF) and by gynecological exam. This represent composite outcome.
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Assessment method [3]
300560
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Timepoint [3]
300560
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5 months after vaginal delivery.
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Secondary outcome [1]
329503
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To estimate strength of pelvic floor. This outcome will be assessed by perineometer and expressed in mmH2O unit.
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Assessment method [1]
329503
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Timepoint [1]
329503
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8 months after vaginal delivery.
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Secondary outcome [2]
330304
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To investigate pelvic organ prolapse. This outcome will be assessed “Pelvic Organ Prolapse Quantification System” (POP–Q).
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Assessment method [2]
330304
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Timepoint [2]
330304
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8 months after vaginal delivery.
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Secondary outcome [3]
330305
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To estimate incidence of stress urinary incontinence. This will be assessed by “International Consultation on Incontinence Questionnaire - Short Form” (ICIQ-SF), by clinical stress testing and by Q-tip test.
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Assessment method [3]
330305
0
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Timepoint [3]
330305
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8 months after vaginal delivery.
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Secondary outcome [4]
330306
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To estimate incidence of fecal incontinence. This will be assessed by “Wexner Fecal Incontinence Score” and by ultrasound introital scan of anal sphincter and levator ani muscle.
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Assessment method [4]
330306
0
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Timepoint [4]
330306
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8 months after vaginal delivery.
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Secondary outcome [5]
330307
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To estimate incidence of sexual dysfunction after birth in the target population. This will be assessed by “Female Sexual Function Index” (FSFI).
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Assessment method [5]
330307
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Timepoint [5]
330307
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8 months after vaginal delivery.
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Eligibility
Key inclusion criteria
The study will include primiparas with singleton pregnancies and spontaneous beginning of labor. Primiparous women in term vaginal deliveries with episiotomy will be included. Primiparous women with intact perineum or with spontaneous perineal rupture of first and second degree but without episiotomy will be included. Fetal cephalic presentation will be inclusion criteria.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria are birth by Caesarean section, peraneal 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.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Power analysis for the independent t-test (the expected difference between the scores of individual tests and assessments incontinence and sexual dysfunction between the test and control groups) according to the following parameters: the expected effect size d = 0.4, the significance level a = 0.05 and power of the test 0.80, the research is supposed to include, at least, 200 respondents, or 100 respondents per group. Power analysis was performed using the computer program G*Power for Windows, version 3.1.3. The analysis of distribution of data normality (Kolmogorov–Smirnov test) will be done. In accordance with the results, the appropriate parametric and / or non-parametric statistical analysis and data display modes will be applied. ROC analysis will determine the sensitivity, specificity, positive and negative predictive value of the diagnostic odds ratio of individual tests in relation to the positive finding of urine and stool incontinence, as well as sexual dysfunction. An appropriate regression model will be used to analyze the prediction of some clinical variables for positive test of urine and stool incontinence and sexual dysfunction. All P values lower than 0.05 will be considered significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
15/02/2016
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Date of last participant enrolment
Anticipated
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Actual
15/04/2017
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Date of last data collection
Anticipated
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Actual
15/12/2017
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Sample size
Target
200
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Accrual to date
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Final
200
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Recruitment outside Australia
Country [1]
8405
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Croatia
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State/province [1]
8405
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Grad Zagreb
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Funding & Sponsors
Funding source category [1]
295013
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Hospital
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Name [1]
295013
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University Hospital "Sveti Duh"
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Address [1]
295013
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Sveti Duh street 64, 10000 Zagreb, Croatia
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Country [1]
295013
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Croatia
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Primary sponsor type
Hospital
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Name
University Hospital "Sveti Duh"
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Address
Sveti Duh street 64, 10000 Zagreb, Croatia
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Country
Croatia
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Secondary sponsor category [1]
293833
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None
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Name [1]
293833
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Address [1]
293833
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Country [1]
293833
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296368
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Ethics committee of the University Hospital "Sveti Duh"
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Ethics committee address [1]
296368
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Sveti Duh street 64, 10000 Zagreb
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Ethics committee country [1]
296368
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Croatia
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Date submitted for ethics approval [1]
296368
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07/09/2015
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Approval date [1]
296368
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21/09/2015
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Ethics approval number [1]
296368
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01-4140
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Summary
Brief summary
Episiotomy is an incision which extends the vestibule of the vagina during fetal expulsion. Most texts describe two types, the mediolateral and the median episiotomy, although there are more types. Lateral episiotomy cut starts 1-2 cm from the posterior fourchette towards the tuberosity of the ischium and is often used but rarely cited in the literature. Primary aim is to explore the effect of lateral episiotomy on the pelvic floor and the occurrence of urinary and fecal incontinence and sexual dysfunction in primiparas as compared to women without episiotomy. This is a prospective cohort study. 200 examinees will be divided in 2 groups. The first group will consists of women who delivered by lateral episiotomy and another group of women who delivered with perineal rupture of lesser degree. The study will include primiparas with singleton pregnancies and spontaneous onset of labor with fetuses in cephalic presentation. Clinical examination of pelvic floor will be performed at time interval of 5 and 8 months after delivery accompanied by specific questionnaires. International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form will assess urinary incontinence, Wexner Scale will assess fecal incontinence while Female Sexual Function Index will assess sexual function. Exam of pelvic floor will be done by Pelvic Organ Prolapse Quantification system, Bonney test, Q-tip test, ultrasound of the anal sphincter and the muscle levator ani plus valuation of the pelvic muscles by perineometry. Evaluation of the effects of lateral episiotomy on the observed indicators of the of women life quality through medium-term outcomes after first delivery, in particular about quality of sexual life, urinary and fecal continence will contribute to a better understanding of recent issues in obstetrics and urogynecology.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
70634
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Dr Kresimir Zivkovic
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Address
70634
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University Hospital "Sveti Duh", Zagreb,
Sveti Duh street 64, 10000 Zagreb, Croatia
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Country
70634
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Croatia
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Phone
70634
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+385981769213
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Fax
70634
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+38513745534
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Email
70634
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[email protected]
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Contact person for public queries
Name
70635
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Kresimir Zivkovic
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Address
70635
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University Hospital "Sveti Duh", Zagreb,
Sveti Duh street 64, 10000 Zagreb, Croatia
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Country
70635
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Croatia
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Phone
70635
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+385981769213
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Fax
70635
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+38513745534
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Email
70635
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[email protected]
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Contact person for scientific queries
Name
70636
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Kresimir Zivkovic
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Address
70636
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University Hospital "Sveti Duh", Zagreb,
Sveti Duh street 64, 10000 Zagreb, Croatia
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Country
70636
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Croatia
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Phone
70636
0
+385981769213
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Fax
70636
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+38513745534
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Email
70636
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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