- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05533307
Mediolateral Episiotomy in Nulliparous Women Increases the Risk of Sexual Dysfunction
Postpartum sexual functions may be affected in women who have had a vaginal delivery by performing an episiotomy. The aim of this study is to compare the frequency of sexual dysfunction between women who were delivered with a mediolateral episiotomy and those who were delivered without an episiotomy.
Materials and Methods: A total of 179 women who gave birth in a tertiary center were included in the prospective study. The patients were divided into two groups as women with and without mediolateral episiotomy. The groups were compared in terms of age, body mass index, educational status, and hospitalization time for delivery and Arizona sexual experiences scale (ASEX).
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Batman, Turkey, 72000
- Batman Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nulliparous women who gave birth at term
- No smoking or alcohol consumption
- Chronic illness
- Spontaneous labor( The labor was defined as cervical dilatation of at least 2cm with at least 80% of effacement with regular contractions or 4cm dilatation with any effacement with regular contractions or the flow of amniotic fluid.
Exclusion Criteria:
- Exclusion criteria were need of labor induction,
- history of any pregnancy complication (gestational diabetes, hypertension, oligohydramnios, any suspicion of infection or chorioamnionitis…etc.),
- history of multiparity,
- history of sexual dysfunction,
- history of vaginal surgery and frequent vaginal infection.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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nulliparous women with normal birth (not needed mediolateral episitomy)/1
group without mediolateral episiotomy
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ASEX (ARİZONA SEXUEL FONCTİON SCORİNG) TEST
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nulliparous women with normal birth (with mediaolateral episiotomy)/2
group with mediolateral episiotomy
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ASEX (ARİZONA SEXUEL FONCTİON SCORİNG) TEST
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of sexuel dysfunction with ASEX(Arizona sexuel fonction scoring)
Time Frame: Sexuel dysfuntion scores after 6 months of normal vaginal birth
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In this study, we prospectively evaluated patients in active labor using ASEX and wanted to investigate the effect of mediolateral episiotomy on female sexual life.
Maximum score of Asex scoring is 24 and minimum score is 0.
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Sexuel dysfuntion scores after 6 months of normal vaginal birth
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EOkuyan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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