NCT04076904

Brief Summary

The developed uterine scar developing due to cesarean section is usually clinically evaluated and visualized by transvaginal sonography (TVS) and saline infusion sonography (SIS) or Gel installation sonography (GIS)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

August 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

August 30, 2019

Last Update Submit

May 21, 2020

Conditions

Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (1)

  • The number of women who will have dehesent scar

    transvaginal us showing lower segment with assessing scar

    within a week

Interventions

transvaginal us with 2D and 3D SHGDIAGNOSTIC_TEST

transvaginal us is made to all women with SHG

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales with a previous section and has secondary infertility
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

In 2015, WHO displayed and reveled a systematic review of the research studies in the scientific literature to evaluate and asses the linkage and connection between cesarean section rates and maternal,

You may qualify if:

  • \- women with secondary infertility

You may not qualify if:

  • obstructed labor, pregnant women having chronic diseases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Algazeerah and Kasralainy hospital

Giza, Egypt

Location

Algazeerah

Giza, Egypt

Location

Related Publications (1)

  • Alalfy M, Osman OM, Salama S, Lasheen Y, Soliman M, Fikry M, Ramadan M, Alaa D, Elshemy S, Abdella R. Evaluation of the Cesarean Scar Niche In Women With Secondary Infertility Undergoing ICSI Using 2D Sonohysterography Versus 3D Sonohysterography and Setting a Standard Criteria; Alalfy Simple Rules for Scar Assessment by Ultrasound To Prevent Health Problems for Women. Int J Womens Health. 2020 Nov 3;12:965-974. doi: 10.2147/IJWH.S267691. eCollection 2020.

    PMID: 33177887DERIVED

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher , lecturer ,Obstetrics and Gynecology , National Research Centre

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 4, 2019

Study Start

October 1, 2019

Primary Completion

January 25, 2020

Study Completion

January 28, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)