NCT05533307

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

September 3, 2022

Last Update Submit

September 8, 2022

Conditions

Keywords

sexuel dysfunctionmediolateraş episiotomy

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

Diagnostic Test: observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birth

nulliparous women with normal birth (with mediaolateral episiotomy)/2

group with mediolateral episiotomy

Diagnostic Test: observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birth

Interventions

ASEX (ARİZONA SEXUEL FONCTİON SCORİNG) TEST

nulliparous women with normal birth (not needed mediolateral episitomy)/1nulliparous women with normal birth (with mediaolateral episiotomy)/2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsnulliparous women with normal vginal birth
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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)

Location

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

Locations