IncontinenceNCT04474275
The Effect of the Mode of Delivery to the Pelvic Floor Function
An observational study of Incontinence and Pelvic Organ Prolapse, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. 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
- Incontinence, Pelvic Organ Prolapse
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 20 Sep 2021
- 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: 18-40 years old primiparous women who gave birth 5-10 years ago.
Who may be able to join
- Primiparous women 5-10 years after birth
Who cannot join
- Multiparous women Women with connective tissue disorders
Trial locations and contacts
1 site in 1 country.
About this study
The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. The investigators wondered if the mode of deliveries such as ceserean section, vaginal route delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor function differently or not. In order to evaluate this, the investigators are planning to measure the muscle tonus in primiparous women.
- Conditions
- Incontinence, Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse
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 |
|---|---|---|
| Study group 1 | Primiparous women who gave birth with ceserean section | |
| Study group 2 | Primiparous women who gave birth with vaginal route delivery without episiotomy | |
| Study group 3 | Primiparous women who gave birth with vaginal route delivery with episiotomy | |
| Control group | Nulliparous women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle tonus
Pelvic floor muscle tonus is going to measure by vaginal perineometry.
Measured: 25.05.2020- 25.08.2020
Secondary outcomes (1)
Female sexual function
Female sexual function is going to evaluate by validated FSFI questionnaire
Measured: 25.05.2020- 25.08.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Jun 2020
- Primary completion20 Aug 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncontinenceStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebnem Alanya Tosun, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474275
- Sponsor's protocol ID
- Mode of Delivery
- Status last verified
- Aug 2021
- First submitted
- 18 Jun 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mode of Delivery to the Pelvic Floor Function
- ClinicalTrials.gov ID
- NCT04474275
- Acronym / sponsor ID
- Mode of Delivery
- Conditions
- Incontinence, Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 16 Jul 2020 (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.
The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. The investigators wondered if the mode of deliveries such as ceserean section, vaginal route delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor function differently or not. In order to evaluate this, the investigators are planning to measure the muscle tonus in primiparous women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | –Primiparous women who gave birth with ceserean section |
| Study group 2 | – | –Primiparous women who gave birth with vaginal route delivery without episiotomy |
| Study group 3 | – | –Primiparous women who gave birth with vaginal route delivery with episiotomy |
| Control group | – | –Nulliparous women |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-40 years old primiparous women who gave birth 5-10 years ago.
Key inclusion criteria (1 listed)
- Primiparous women 5-10 years after birth
Key exclusion criteria (1 listed)
- Multiparous women Women with connective tissue disorders
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
Pelvic floor muscle tonus
Time frame: 25.05.2020- 25.08.2020
Pelvic floor muscle tonus is going to measure by vaginal perineometry.
1 secondary outcome
Female sexual function
Time frame: 25.05.2020- 25.08.2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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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 Incontinence and Pelvic Organ Prolapse, run by Giresun University 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 1 inclusion and 1 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 6 Aug 2021. 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?
Results are not available in the source record.
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?
Pelvic floor muscle tonus (time frame: 25.05.2020- 25.08.2020). 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 6 Aug 2021.