Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche
- Conditions
- Anteversion of UterusRetroflex UterusCSD
- Interventions
- Diagnostic Test: Caesarean scar defect evlauation by ultraosund
- Registration Number
- NCT06475924
- Lead Sponsor
- Ain Shams University
- Brief 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 86
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cesarean Scar Defect (CSD) Caesarean scar defect evlauation by ultraosund 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
- Primary Outcome Measures
Name Time Method correlation between position of the uterus and large Cesarean Scar defect (CSD) 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)
- Secondary Outcome Measures
Name Time Method correlation between position of uterus and postmenstrual spotting 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), 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)
correlation between position of uterus and Pelvic Pain 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), and correlates it to the presence of Dysmenorrhea, Chronic pelvic pain or dyspareunia.
correlation between position of uterus and Residual myometrial thickness 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), and measuring the thickness of the myometrium over the SCD (mm)
correlation between position of uterus and Depth, Length, Width of SCD 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), 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.
correlation between position of uterus and Abnormal Uterine Bleeding (AUB) 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), 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
correlation between position of uterus and secondary infertility through study completion, up to 6 months secondary infertility is defined as inability of a couple to conceive after 1 year of regular, unprotected intercourse.
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Egypt