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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05533307
Other study ID # EOkuyan
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2019
Est. completion date August 8, 2022

Study information

Verified date September 2022
Source Batman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

All patients were called up for a control in 6th month after delivery and sexual funciton was evaluated according to The Arizona Sexual Experience Scale (ASEX). In our study, we used the ASEX test, age, education level, BMI and time spent in hospital for delivery to investigate sexual dysfunction in healthy women who had a vaginal delivery with or without mediolateral episiotomy. The ASEX test is a 5-question survey. In the questionnaire, women were questioned for sexual drive, arousal, vaginal lubrication, ability to reach orgasm, satisfaction from the orgasm. Women gave points from 1 to 6 and their results were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 8, 2022
Est. primary completion date September 15, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birth
ASEX (ARIZONA SEXUEL FONCTION SCORING) TEST

Locations

Country Name City State
Turkey Batman Training and Research Hospital Batman

Sponsors (1)

Lead Sponsor Collaborator
Batman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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Completed NCT05282160 - The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function. N/A
Completed NCT06370910 - Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction N/A