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Completed

NCT Number: NCT06475924

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

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?

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Key information

Conditions

Anteversion of Uterus CSD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Retroflex Uterus Torsion Abnormality Urogenital Diseases Uterine Diseases Uterine Retroversion

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caesarean scar defect evlauation by ultraosund

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. correlation between position of uterus and Residual myometrial thickness

    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), and measuring the thickness of the myometrium over the SCD (mm)

  2. correlation between position of uterus and Depth, Length, Width of SCD

    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), 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.

  3. correlation between position of uterus and postmenstrual spotting

    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), 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)

  4. correlation between position of uterus and Abnormal Uterine Bleeding (AUB)

    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), 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

  5. correlation between position of uterus and Pelvic Pain

    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), and correlates it to the presence of Dysmenorrhea, Chronic pelvic pain or dyspareunia.

  6. correlation between position of uterus and secondary infertility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche : Cross -Sectional Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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