Incidence of Uterine Cesarean Scar Niche After Cesarean Delivery

NCT ID: NCT05900492

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-09-30

Brief Summary

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To assess the incidence of cesarean scar niche and its risk factors in a prospectively collected population.

Detailed Description

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It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital using Ultrasound:

Six months after the cesarean delivery, participants will be invited to the gynecologic outpatient clinic or department for ultrasound (US) examination to detect the presence of the niche.

Women without contraception will be examined during the follicular phase of the menstrual cycle to avoid an eventual early pregnancy. Otherwise, a random phase of the menstrual cycle will be accepted. Women who are pregnant at the time of US will be excluded. Women will be examined in the lithotomy position with an empty bladder. The uterus will be examined in a standardized way, with trans-vaginal US performed first.

For the diagnosis of cesarean scar niche (defined as an anechoic defect in the anterior wall of the lower uterine segment, communicating with the endometrial cavity),we will use a predetermined definition of a defect at least 2.0 mm deep

Conditions

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Cesarean Section Dehiscence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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previous 1 cesarean section

patient who had her first Cesarean section

cesarean section

Intervention Type PROCEDURE

caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen

previous 2 cesarean sections

patient who had her second Cesarean sections

cesarean section

Intervention Type PROCEDURE

caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen

previous 3 or more cesarean sections

patient who had 3 or more Cesarean sections

cesarean section

Intervention Type PROCEDURE

caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen

Interventions

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cesarean section

caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Delivery by cesarean section.
2. More than 6 months after delivery.
3. Cesarean section by senior resident or assistant lecturer.

Exclusion Criteria

1. Single layer technique in uterine closure.
2. Uterine anomaly.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sara M salem, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Beni-Suef University

Locations

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Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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cesarean scar niche R.F

Identifier Type: -

Identifier Source: org_study_id

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