Anteversion of UterusNCT06475924
Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche
A study testing Caesarean scar defect evlauation by ultraosund in people with Anteversion of Uterus and Retroflex Uterus, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to determine the association between the size of caesarean scar niche and uterine position in childbearing women. Research hypothesis: There is a relation between uterine position and degree of cesarean scar niche. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Anteversion of Uterus, Retroflex Uterus, CSD
- What is being tested?
- Caesarean scar defect evlauation by ultraosund
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women in childbearing age.
- At least six months postpartum.
- With cesarean scar niche/defect (CSD) by transvaginal ultrasound that is defined as "indentation at the site in the cesarean section scar with a depth of at least 2 mm" that was agreed upon in 2019 by a European task force
Who cannot join
- Severely Obese (Body mass index; BMI more than or equal to 35 kg/m2).
- Women with abnormal uterine pathology, observed during the ultrasound examination that may have been responsible for abnormal uterine bleeding, including endometrial hyperplasia, polyps, malignancy or myomas.
- Women with any cause of pelvic pain as pelvic inflammatory diseases, endometriosis or adenomyosis.
- Women with history of classic upper segment cesarean section or hysterotomy.
- Women with history of previous uterine scars rather than cesarean sections as myomectomy.
- Women with bleeding tendency disorders, taking anticoagulants or having chronic medical conditions as liver diseases, or coagulopathies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche : Cross -Sectional Study
This study aims to determine the association between the size of caesarean scar niche and uterine position in childbearing women.
Research hypothesis: There is a relation between uterine position and degree of cesarean scar niche.
Research question: Is there a relation between uterine position and degree of cesarean scar niche?
Read the detailed description
It has been noted that the cesarean scar defect in patients with retroflexed uteri appear to be larger than are those in patients with anteverted uteri.
This study will describe the association between position of the uterus whether share in degree of cesarean scar niche or not and associated symptoms.
Primary outcome:
The association between the position of the uterus (Anteverted/Retroverted) and large CSD (the ratio between the depth and adjacent myometrial thickness)
Secondary outcomes:
The association between position of the uterus (Anteverted/Retroverted) and:
- Residual myometrial thickness (RMT).
- Depth, Width, Length of SCD.
The association to the clinical symptoms as:
- Postmenstrual spotting: more than 2 days of intermenstrual spotting, or more than 2 days of brownish discharge after the end of menstruation if bleeding duration exceeds 7 days (discharge is considered normal if bleeding duration is < 7 days).
- Abnormal uterine bleeding (AUB) as per FIGO guideline.
- Pain as dysmenorrhea, chronic pelvic pain or dyspareunia. If present will be assed using Visual Analogue Scale (VAS).
- Secondary infertility: inability of a couple to conceive after one year of regular, unprotected intercourse.
- Conditions
- Anteversion of Uterus, Retroflex Uterus, CSD
- Being tested
- Caesarean scar defect evlauation by ultraosund
- Keywords
- Cesarean scar defefect, Isthmocele, Caesarean scar niche, Anteverted uterus, Retroverted uterus
- Medical subject headings
- Uterine Retroversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caesarean scar defect evlauation by ultraosundDiagnostic test
Women will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way excluding causes of abnormal uterine bleeding or pelvic pain (myoma, polyp, pelvic inflammatory disease, adenomyosis).
Upon detection of the SCD, the following will be measured:
In the midsagittal plane: the depth (the vertical distance between the base and apex of the defect), width (the length of the widest gap along the cervicoisthmic canal), residual myometrial thickness (RMT) overlying the defect, and the adjacent myometrial thickness fundal to the defect.
In the transverse plane: the length of the defect.
The uterine position will be classified as anteverted or retroverted.
Clinical symptoms of the patients will be reviewed such as :Postmenstrual spotting, Abnormal uterine bleeding, Pain, Secondary infertility.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Scar Defect (CSD) | Other | cesarean scar niche/defect (CSD) by transvaginal ultrasound that is defined as "indentation at the site in the cesarean section scar with a depth of at least 2 mm" that was agreed upon in 2019 by a European task force Receives: Diagnostic Test: Caesarean scar defect evlauation by ultraosund |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between position of the uterus and large Cesarean Scar defect (CSD)
By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), which will be correlated to the presence of Large CSD (ratio between the depth (mm) and adjacent myometrial thickness (mm) more than or equal to 0.50)
Measured: through study completion, up to 6 months
Secondary outcomes (6)
correlation between position of uterus and Residual myometrial thickness
By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), and measuring the thickness of the myometrium over the SCD (mm)
Measured: through study completion, up to 6 months
correlation between position of uterus and Depth, Length, Width of SCD
By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), and measure depth (mm) and width (mm) of the Cesarean scar defect, while in transverse plane of the uterus measure length (mm) of the cesarean scar defect.
Measured: through study completion, up to 6 months
correlation between position of uterus and postmenstrual spotting
By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), and correlates to the presence of more than or equal to 2 days of intermenstrual spotting or more than or equal to 2 days of brownish discharge after the end of menstruation if bleeding duration exceeds 7 days (discharge is considered normal if bleeding duration is less than 7 days)
Measured: through study completion, up to 6 months
correlation between position of uterus and Abnormal Uterine Bleeding (AUB)
By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), and correlates to the presence of AUB as per Figo guideline as regards frequency (in days), duration (in days), regularity (Regular/irregular) and intermenstrual bleeding
Measured: through study completion, up to 6 months
correlation between position of uterus and Pelvic Pain
By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), and correlates it to the presence of Dysmenorrhea, Chronic pelvic pain or dyspareunia.
Measured: through study completion, up to 6 months
correlation between position of uterus and secondary infertility
secondary infertility is defined as inability of a couple to conceive after 1 year of regular, unprotected intercourse.
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start15 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anteversion of UterusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Abdelrazek, Ain Shams University
- Investigators
- Maya M. Abdelrazek, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475924
- Sponsor's protocol ID
- MS 522/2023
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2024
- Last updated
- 20 Aug 2024
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche : Cross -Sectional Study
- ClinicalTrials.gov ID
- NCT06475924
- Acronym / sponsor ID
- MS 522/2023
- Conditions
- Anteversion of Uterus, Retroflex Uterus, CSD
- Keywords
- Cesarean scar defefect, Isthmocele, Caesarean scar niche, Anteverted uterus, Retroverted uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Jun 2024 (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.
This study aims to determine the association between the size of caesarean scar niche and uterine position in childbearing women.
Research hypothesis: There is a relation between uterine position and degree of cesarean scar niche.
Research question: Is there a relation between uterine position and degree of cesarean scar niche?
Detailed description
It has been noted that the cesarean scar defect in patients with retroflexed uteri appear to be larger than are those in patients with anteverted uteri.
This study will describe the association between position of the uterus whether share in degree of cesarean scar niche or not and associated symptoms.
Primary outcome:
The association between the position of the uterus (Anteverted/Retroverted) and large CSD (the ratio between the depth and adjacent myometrial thickness)
Secondary outcomes:
The association between position of the uterus (Anteverted/Retroverted) and:
- Residual myometrial thickness (RMT).
- Depth, Width, Length of SCD.
The association to the clinical symptoms as:
- Postmenstrual spotting: more than 2 days of intermenstrual spotting, or more than 2 days of brownish discharge after the end of menstruation if bleeding duration exceeds 7 days (discharge is considered normal if bleeding duration is < 7 days).
- Abnormal uterine bleeding (AUB) as per FIGO guideline.
- Pain as dysmenorrhea, chronic pelvic pain or dyspareunia. If present will be assed using Visual Analogue Scale (VAS).
- Secondary infertility: inability of a couple to conceive after one year of regular, unprotected intercourse.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean Scar Defect (CSD) | Other | Diagnostic Test: Caesarean scar defect evlauation by ultraosundcesarean scar niche/defect (CSD) by transvaginal ultrasound that is defined as "indentation at the site in the cesarean section scar with a depth of at least 2 mm" that was agreed upon in 2019 by a European task force |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women in childbearing age.
- At least six months postpartum.
- With cesarean scar niche/defect (CSD) by transvaginal ultrasound that is defined as "indentation at the site in the cesarean section scar with a depth of at least 2 mm" that was agreed upon in 2019 by a European task force
Key exclusion criteria (6 listed)
- Severely Obese (Body mass index; BMI more than or equal to 35 kg/m2).
- Women with abnormal uterine pathology, observed during the ultrasound examination that may have been responsible for abnormal uterine bleeding, including endometrial hyperplasia, polyps, malignancy or myomas.
- Women with any cause of pelvic pain as pelvic inflammatory diseases, endometriosis or adenomyosis.
- Women with history of classic upper segment cesarean section or hysterotomy.
- Women with history of previous uterine scars rather than cesarean sections as myomectomy.
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 |
|---|---|---|
| Caesarean scar defect evlauation by ultraosundWomen will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way excluding causes of abnormal uterine bleeding or pelvic pain (myoma, polyp, pelvic inflammatory disease, adenomyosis). Upon detection of the SCD, the following will be measured: In the midsagittal plane: the depth (the vertical distance between the base and apex of the defect), width (the length of the widest gap along the cervicoisthmic canal), residual myometrial thickness (RMT) overlying the defect, and the adjacent myometrial thickness fundal to the defect. In the transverse plane: the length of the defect. The uterine position will be classified as anteverted or retroverted. Clinical symptoms of the patients will be reviewed such as :Postmenstrual spotting, Abnormal uterine bleeding, Pain, Secondary infertility. | Diagnostic test | Cesarean Scar Defect (CSD) |
Primary outcome
correlation between position of the uterus and large Cesarean Scar defect (CSD)
Time frame: through study completion, up to 6 months
By using transvaginal ultrasound, the uterus will be examined in a mid sagittal plane to evaluate the position of the uterus that will be described as (Anteverted: the uterus tilts forward at the cervix/ Retroverted: the uterus tilts backward at the cervix), which will be correlated to the presence of Large CSD (ratio between the depth (mm) and adjacent myometrial thickness (mm) more than or equal to 0.50)
6 secondary outcomes
correlation between position of uterus and Residual myometrial thickness
Time frame: through study completion, up to 6 months
correlation between position of uterus and Depth, Length, Width of SCD
Time frame: through study completion, up to 6 months
correlation between position of uterus and postmenstrual spotting
Time frame: through study completion, up to 6 months
correlation between position of uterus and Abnormal Uterine Bleeding (AUB)
Time frame: through study completion, up to 6 months
correlation between position of uterus and Pelvic Pain
Time frame: through study completion, up to 6 months
correlation between position of uterus and secondary infertility
Time frame: through study completion, up to 6 months
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 20 Aug 2024.
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.
Maya M. Abdelrazek principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caesarean scar defect evlauation by ultraosund in people with Anteversion of Uterus and Retroflex Uterus, run by Ain Shams 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 3 inclusion and 6 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 20 Aug 2024. 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?
correlation between position of the uterus and large Cesarean Scar defect (CSD) (time frame: through study completion, up to 6 months). 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 20 Aug 2024.