Sexual Dysfunction and the Mode of DeliveriesNCT03449355
Sexuality After Different Mode of Deliveris
An observational study of Sexual Dysfunction and the Mode of Deliveries, run by Mansoura University at 1 site in Egypt.
Trial summary
Pregnancy and delivery usually affect the general women's quality of life. Some studies have reported that sexual health may be affected by the mode of delivery. More than 70% of pregnant women prefer C-section due to several reasons point out the fear of pain and complications of vaginal delivery as the most common… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Sexual Dysfunction and the Mode of Deliveries
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jan 2018to 1 Mar 2018
- 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 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Study population: primiparous women 6-12 months after deliveries either vaginal or cesarean section
Who may be able to join
- Primiparas women who had been delivered by either vaginal or cesarean section about 6-12months.
- All included women should be officially married
Who cannot join
- Women with history of sexual dysfunction
- Women with history of any pelvic surgery apart from Cesarean.
- history of anti-depressive drug therapy.
- history of genital prolapse
- history of Diabetes mellitus
- loss of any family member or unfaveorouble neonatal outcome or childdeath
- Divorce experience
- family problems and cases who were not interested in participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Mode of Delivery on Sexual Functions and Quality of Life Among a Group of Egyptian Women
Pregnancy and delivery usually affect the general women's quality of life. Some studies have reported that sexual health may be affected by the mode of delivery. More than 70% of pregnant women prefer C-section due to several reasons point out the fear of pain and complications of vaginal delivery as the most common reasons.
Aim of the work: To explore the relationship between quality of life and the possible sexual dysfunction after normal vaginal in comparison to cesarean section deliveries.
- Keywords
- sexuality, mode of delivery, quality of life
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vaginal group | Not described | |
| cesarean section group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life after delivery
the amplitude of many changes occur during and after pregnancy, which affect physical, psychological and social health and generally women's quality of life
Measured: one month
Secondary outcomes (1)
the relationship between quality of life and sexual dysfunction after both modes delivery
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start11 Jan 2018
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Dysfunction and the Mode of DeliveriesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Nabil, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449355
- Sponsor's protocol ID
- sexuality
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Mode of Delivery on Sexual Functions and Quality of Life Among a Group of Egyptian Women
- ClinicalTrials.gov ID
- NCT03449355
- Acronym / sponsor ID
- sexuality
- Keywords
- sexuality, mode of delivery, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 28 Feb 2018 (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.
Pregnancy and delivery usually affect the general women's quality of life. Some studies have reported that sexual health may be affected by the mode of delivery. More than 70% of pregnant women prefer C-section due to several reasons point out the fear of pain and complications of vaginal delivery as the most common reasons.
Aim of the work: To explore the relationship between quality of life and the possible sexual dysfunction after normal vaginal in comparison to cesarean section deliveries.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginal group | – | – |
| cesarean section group | – | – |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primiparous women 6-12 months after deliveries either vaginal or cesarean section
Key inclusion criteria (2 listed)
- Primiparas women who had been delivered by either vaginal or cesarean section about 6-12months.
- All included women should be officially married
Key exclusion criteria (8 listed)
- Women with history of sexual dysfunction
- Women with history of any pelvic surgery apart from Cesarean.
- history of anti-depressive drug therapy.
- history of genital prolapse
- history of Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quality of life after delivery
Time frame: one month
the amplitude of many changes occur during and after pregnancy, which affect physical, psychological and social health and generally women's quality of life
1 secondary outcome
the relationship between quality of life and sexual dysfunction after both modes delivery
Time frame: one month
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 3 Apr 2018.
Related trials for Sexual Dysfunction and the Mode of Deliveries
Enrolling by invitationObservational study
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Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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 Sexual Dysfunction and the Mode of Deliveries, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 8 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 3 Apr 2018. 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 Egypt. 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?
quality of life after delivery (time frame: one month). 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 3 Apr 2018.