Pelvic Floor DisordersNCT03126604
Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women
An observational study of Pelvic Floor Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- female sexual function index
- How many people
- 5,000 participants
- Where
- 1 siteEgypt
- Study dates
- May 2017to Jan 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women who delivered vaginally or Cesarean for the first time within 6 months to 5 years before evaluation
Who may be able to join
- primiparity,
- singleton pregnancy
- cephalic presentation
- term delivery (38-42 weeks).
Who cannot join
- Women with operative vaginal delivery (vacuum extraction or forceps delivery)
- women who had another delivery between the time of first one and time of evaluation
- women with neurological diseases
- women with vascular diseases and Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women
A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section
Read the detailed description
A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Four separate entities were evaluated using internationally recognized and validated questionnaires:
- Pelvic organ prolapse evaluated using the Pelvic Organ Prolapse Distress Inventory
- Urinary functions were evaluated using the International Consultation on Incontinence Questionnaire Short Form
- Fecal incontinence was evaluated using Wexner Fecal Incontinence Score
- Sexual functions were evaluated using female sexual function index
- Conditions
- Pelvic Floor Disorders
- Being tested
- female sexual function index
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
female sexual function indexDiagnostic test
evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions
| Study group | Role | What they receive |
|---|---|---|
| vaginal delivery | Women underwent non complicated non instumental normal vaginal delivery Receives: Diagnostic Test: female sexual function index | |
| Cesarean section | Women underwent elective Cesarean section Receives: Diagnostic Test: female sexual function index |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary incontinence
evaluation using the International Consultation on Incontinence Questionnaire Short Form
Measured: 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126604
- Sponsor's protocol ID
- 5
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women
- ClinicalTrials.gov ID
- NCT03126604
- Acronym / sponsor ID
- 5
- Conditions
- Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 24 Apr 2017 (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.
A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section
Detailed description
A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Four separate entities were evaluated using internationally recognized and validated questionnaires:
- Pelvic organ prolapse evaluated using the Pelvic Organ Prolapse Distress Inventory
- Urinary functions were evaluated using the International Consultation on Incontinence Questionnaire Short Form
- Fecal incontinence was evaluated using Wexner Fecal Incontinence Score
- Sexual functions were evaluated using female sexual function index
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginal delivery | – | Diagnostic Test: female sexual function indexWomen underwent non complicated non instumental normal vaginal delivery |
| Cesarean section | – | Diagnostic Test: female sexual function indexWomen underwent elective Cesarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women who delivered vaginally or Cesarean for the first time within 6 months to 5 years before evaluation
Key inclusion criteria (4 listed)
- primiparity,
- singleton pregnancy
- cephalic presentation
- term delivery (38-42 weeks).
Key exclusion criteria (4 listed)
- Women with operative vaginal delivery (vacuum extraction or forceps delivery)
- women who had another delivery between the time of first one and time of evaluation
- women with neurological diseases
- women with vascular diseases and 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| female sexual function indexevaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions | Diagnostic test | Cesarean section, vaginal delivery |
Primary outcome
urinary incontinence
Time frame: 6 months after delivery
evaluation using the International Consultation on Incontinence Questionnaire Short Form
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: Yes
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Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
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Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
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Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
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 Pelvic Floor Disorders, run by Cairo 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 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: status not confirmed, as of the sponsor's last update on 24 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary incontinence (time frame: 6 months after delivery). 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 24 Apr 2017.