Clinical trial NCT06475924: Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche
Official title: Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche : Cross -Sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anteversion of Uterus
Retroflex Uterus
CSD
Keywords: Cesarean scar defefect
Isthmocele
Caesarean scar niche
Anteverted uterus
Retroverted uterus
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: correlation between position of the uterus and large Cesarean Scar defect (CSD)
timeFrame: through study completion, up to 6 months
Secondary outcomes:
measure: correlation between position of uterus and Residual myometrial thickness
timeFrame: through study completion, up to 6 months
measure: correlation between position of uterus and Depth, Length, Width of SCD
timeFrame: through study completion, up to 6 months
measure: correlation between position of uterus and postmenstrual spotting
timeFrame: through study completion, up to 6 months
measure: correlation between position of uterus and Abnormal Uterine Bleeding (AUB)
timeFrame: through study completion, up to 6 months
measure: correlation between position of uterus and Pelvic Pain
timeFrame: through study completion, up to 6 months
measure: correlation between position of uterus and secondary infertility
timeFrame: through study completion, up to 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Maya M. Abdelrazek
role: PRINCIPAL_INVESTIGATOR
References: