Episiotomy; ComplicationsNCT05533307
Mediolateral Episiotomy in Nulliparous Women Increases the Risk of Sexual Dysfunction
An observational study of Episiotomy; Complications, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Episiotomy; Complications
- What is being tested?
- observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birth
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2019to 8 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman Training and Research Hospital
Batman, 72000
About this study
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).
Read the detailed 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.
- Conditions
- Episiotomy; Complications
- Being tested
- observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birth
- Keywords
- sexuel dysfunction, mediolateraş episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birthDiagnostic test
ASEX (ARİZONA SEXUEL FONCTİON SCORİNG) TEST
| Study group | Role | What they receive |
|---|---|---|
| nulliparous women with normal birth (not needed mediolateral episitomy)/1 | group without mediolateral episiotomy Receives: 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 Receives: Diagnostic Test: observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Sexuel dysfuntion scores after 6 months of normal vaginal birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start10 Sep 2019
- Primary completion15 Sep 2021
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533307
- Sponsor's protocol ID
- EOkuyan
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediolateral Episiotomy in Nulliparous Women Increases the Risk of Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT05533307
- Acronym / sponsor ID
- EOkuyan
- Conditions
- Episiotomy; Complications
- Keywords
- sexuel dysfunction, mediolateraş episiotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nulliparous women with normal birth (not needed mediolateral episitomy)/1 | – | Diagnostic Test: observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birthgroup without mediolateral episiotomy |
| nulliparous women with normal birth (with mediaolateral episiotomy)/2 | – | Diagnostic Test: observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birthgroup with mediolateral episiotomy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational analysis of mediolateral episiotomy with arizona sexuel function scoring after 3 months of normal vaginal birthASEX (ARİZONA SEXUEL FONCTİON SCORİNG) TEST | Diagnostic test | nulliparous women with normal birth (not needed mediolateral episitomy)/1, nulliparous women with normal birth (with mediaolateral episiotomy)/2 |
Primary outcome
Evaluation of sexuel dysfunction with ASEX(Arizona sexuel fonction scoring)
Time frame: Sexuel dysfuntion scores after 6 months of normal vaginal birth
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Episiotomy; Complications, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sexuel dysfunction with ASEX(Arizona sexuel fonction scoring) (time frame: Sexuel dysfuntion scores after 6 months of normal vaginal birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.