Hysteroscopic Evaluation of Cesarean Scar Defect

Hysteroscopic Evaluation of Cesarean Scar Defect Features & Its Correlation With Women Complaints

The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations.

Study Overview

• Status: Unknown
• Conditions: Cesarean Scar Defect
• Intervention / Treatment: Procedure: Diagnostic hysteroscopic examination

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Egypt
  • Abbassya
    • Cairo, Abbassya, Egypt, 11566
      • Recruiting
      • Ainshams University maternity hospital
      • Contact: Radwa R Ali, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study will be carried on 200 patients with cesarean scar defect recruited from Early Cancer Detection Unit.

Description

Inclusion Criteria:

1. Age between 18 and 35 years.
2. Had at least one prior cesarean section

Exclusion Criteria:

1. History of uterine surgery that could change the cavity anatomy.
2. Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.
3. Recent intra-uterine contraceptive device (IUCD) in place.
4. Known history of endometriosis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cesarean section scar defect shapes	different shapes of CS defect and its relation to post menstrual spotting	at least six months after CS

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Ain Shams University H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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