Mediolateral Episiotomy in Nulliparous Women Increases the Risk of Sexual Dysfunction
1 other identifier
observational
180
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2022
CompletedFirst Submitted
Initial submission to the registry
September 3, 2022
CompletedFirst Posted
Study publicly available on registry
September 9, 2022
CompletedSeptember 13, 2022
September 1, 2022
2 years
September 3, 2022
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of sexuel dysfunction with ASEX(Arizona sexuel fonction scoring)
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.
Sexuel dysfuntion scores after 6 months of normal vaginal birth
Study Arms (2)
nulliparous women with normal birth (not needed mediolateral episitomy)/1
group without mediolateral episiotomy
nulliparous women with normal birth (with mediaolateral episiotomy)/2
group with mediolateral episiotomy
Interventions
ASEX (ARİZONA SEXUEL FONCTİON SCORİNG) TEST
Eligibility Criteria
Nulliparous women who gave birth with or without mediolateral episiotomy at Batman training and research hospital will noted individually. After 3 months of birth all included patients will have an ASEX test for sexuel dysfunction analyse.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Batman Training and Research Hospital
Batman, 72000, Turkey (Türkiye)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D,Obstetric and gynecology division
Study Record Dates
First Submitted
September 3, 2022
First Posted
September 9, 2022
Study Start
September 10, 2019
Primary Completion
September 15, 2021
Study Completion
August 8, 2022
Last Updated
September 13, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share