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

A

Ain Shams University

Status

Completed

Conditions

Retroflex Uterus
Anteversion of Uterus
CSD

Treatments

Diagnostic Test: Caesarean scar defect evlauation by ultraosund

Study type

Interventional

Funder types

Other

Identifiers

NCT06475924
MS 522/2023

Details and patient eligibility

About

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?

Full 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.

Enrollment

86 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

86 participants in 1 patient group

Cesarean Scar Defect (CSD)
Other group
Description:
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
Treatment:
Diagnostic Test: Caesarean scar defect evlauation by ultraosund

Trial contacts and locations

1

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Central trial contact

Maya M. Abdelrazek

Data sourced from clinicaltrials.gov

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