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

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?

Study Overview

• Status: Completed
• Conditions: Anteversion of Uterus; Retroflex Uterus; CSD
• Intervention / Treatment: Diagnostic test: Caesarean scar defect evlauation by ultraosund

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	through study completion, up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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)	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	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.	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.	through study completion, up to 6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Maya M. Abdelrazek, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Isthmocele; Cesarean scar defefect; Caesarean scar niche; Anteverted uterus; Retroverted uterus
• Other Study ID Numbers: MS 522/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No