NCT03780699

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

December 16, 2018

Last Update Submit

December 18, 2018

Conditions

Cesarean Scar Defect

Outcome Measures

Primary Outcomes (1)

  • cesarean section scar defect shapes

    different shapes of CS defect and its relation to post menstrual spotting

    at least six months after CS

Interventions

Diagnostic hysteroscopic examinationPROCEDURE

The hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, 11566, Egypt

RECRUITING

Central Study Contacts

Radwa R Ali, MD

CONTACT

01283492979radwaebed@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2018

First Posted

December 19, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

September 1, 2019

Last Updated

December 20, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)