NCT03862820

Brief Summary

  1. 1.To validate the use of dynamic ultrasound for prediction of adhesions in women undergoing repeated cesarean section.
  2. 2.To detect the interobserver and intraobserver reliability of this method

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

March 1, 2019

Last Update Submit

March 10, 2019

Conditions

Obstetric Labor Complications

Outcome Measures

Primary Outcomes (1)

  • presence of abdominal adhesion intra operative

    mobile uterus against uterine wall

    1 year

Interventions

dynamic ultrasoundDIAGNOSTIC_TEST

move abdomen with ultrasound probe to predict intraabdominal adhesions

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women planned for elective repeated section

You may qualify if:

  • Pregnant women in third trimester planned to undergo elective cesarean section

You may not qualify if:

  • Primary elective cesarean section.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ali Yosef

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Yosef, MD

CONTACT

00201005602284aliharoun84@yahoo.com

Study Design

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

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 5, 2019

Study Start

April 1, 2019

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share