NCT04605328

Brief Summary

The study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 5, 2020

Last Update Submit

October 31, 2020

Conditions

Cesarean Section Complications

Keywords

niche

Outcome Measures

Primary Outcomes (1)

  • the incidence of CSD in Women health Hospital

    the incidence of CSD in Women health Hospital

    1 year

Interventions

Two dimension and three dimension ultrasoundOTHER

Patient will undergo 2D and 3D ultrasound evaluation after CS for detection of CSD

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to Women Health Hospital for performing CS will be seen on regular visits for ultrasound scan for detection of CSD

You may qualify if:

  • All women who will undergo transverse lower segment cesarean section after 28 weeks gestational age (electively and Emergency), after counseling and written consent

You may not qualify if:

  • Rupture uterus (unscarred or scarred).
  • Upper segment CS.
  • Vertical lower segment CS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ayman shamaash, PHD

    Assiut University

    STUDY DIRECTOR

  • Sherif Badran, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mohamed Bahaa El-Dine, Master

CONTACT

++201022422960midobahaa39@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 28, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

November 3, 2020

Record last verified: 2020-10