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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
Scientific title
Effects of lateral episiotomy on the function of pelvic floor and sexual function after vaginal delivery in primiparas
Secondary ID [1] 290587 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor dysfunction post vaginal delivery. 301047 0
Condition category
Condition code
Reproductive Health and Childbirth 300836 300836 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 296450 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 300252 0
To investigate duration of second stage of labor on the basis of data collected from medical records.
Timepoint [1] 300252 0
5 months after vaginal delivery.
Primary outcome [2] 300253 0
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.
Timepoint [2] 300253 0
5 months after vaginal delivery.
Primary outcome [3] 300560 0
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.
Timepoint [3] 300560 0
5 months after vaginal delivery.
Secondary outcome [1] 329503 0
To estimate strength of pelvic floor. This outcome will be assessed by perineometer and expressed in mmH2O unit.
Timepoint [1] 329503 0
8 months after vaginal delivery.
Secondary outcome [2] 330304 0
To investigate pelvic organ prolapse. This outcome will be assessed “Pelvic Organ Prolapse Quantification System” (POP–Q).
Timepoint [2] 330304 0
8 months after vaginal delivery.
Secondary outcome [3] 330305 0
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.
Timepoint [3] 330305 0
8 months after vaginal delivery.
Secondary outcome [4] 330306 0
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.
Timepoint [4] 330306 0
8 months after vaginal delivery.
Secondary outcome [5] 330307 0
To estimate incidence of sexual dysfunction after birth in the target population. This will be assessed by “Female Sexual Function Index” (FSFI).
Timepoint [5] 330307 0
8 months after vaginal delivery.

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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2016
Date of last participant enrolment
Anticipated
Actual
15/04/2017
Date of last data collection
Anticipated
Actual
15/12/2017
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 8405 0
Croatia
State/province [1] 8405 0
Grad Zagreb

Funding & Sponsors
Funding source category [1] 295013 0
Hospital
Name [1] 295013 0
University Hospital "Sveti Duh"
Country [1] 295013 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital "Sveti Duh"
Address
Sveti Duh street 64, 10000 Zagreb, Croatia
Country
Croatia
Secondary sponsor category [1] 293833 0
None
Name [1] 293833 0
Address [1] 293833 0
Country [1] 293833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296368 0
Ethics committee of the University Hospital "Sveti Duh"
Ethics committee address [1] 296368 0
Ethics committee country [1] 296368 0
Croatia
Date submitted for ethics approval [1] 296368 0
07/09/2015
Approval date [1] 296368 0
21/09/2015
Ethics approval number [1] 296368 0
01-4140

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70634 0
Dr Kresimir Zivkovic
Address 70634 0
University Hospital "Sveti Duh", Zagreb,
Sveti Duh street 64, 10000 Zagreb, Croatia
Country 70634 0
Croatia
Phone 70634 0
+385981769213
Fax 70634 0
+38513745534
Email 70634 0
kresimirzivkovic@yahoo.com
Contact person for public queries
Name 70635 0
Kresimir Zivkovic
Address 70635 0
University Hospital "Sveti Duh", Zagreb,
Sveti Duh street 64, 10000 Zagreb, Croatia
Country 70635 0
Croatia
Phone 70635 0
+385981769213
Fax 70635 0
+38513745534
Email 70635 0
kresimirzivkovic@yahoo.com
Contact person for scientific queries
Name 70636 0
Kresimir Zivkovic
Address 70636 0
University Hospital "Sveti Duh", Zagreb,
Sveti Duh street 64, 10000 Zagreb, Croatia
Country 70636 0
Croatia
Phone 70636 0
+385981769213
Fax 70636 0
+38513745534
Email 70636 0
kresimirzivkovic@yahoo.com

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No Supporting Document Provided



Results publications and other study-related documents

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