Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche

NCT ID: NCT06475924

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2024-06-30

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.

Conditions

Anteversion of Uterus; Retroflex Uterus; CSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cesarean Scar Defect (CSD)

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

Group Type: OTHER

Caesarean scar defect evlauation by ultraosund

Intervention Type: DIAGNOSTIC_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.

Interventions

Caesarean scar defect evlauation by ultraosund

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Maya Abdelrazek

dr_maya89@med.asu.edu.eg

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maya M. Abdelrazek

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS 522/2023

Identifier Type: -

Identifier Source: org_study_id