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NCT02736058 Clinical Trial

Surgical Classification of Abnormal Placentation

Adherent Placenta Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02736058
Other study ID # PP2202016
Secondary ID
Status Recruiting
Phase N/A
First received February 22, 2016
Last updated May 28, 2016
Start date February 2016
Est. completion date December 2016

Study information
Verified date May 2016
Source Cairo University
Contact Ahmed M Hussein, MD
Phone 01223515652
Email ahmed_mhussein@live.com
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- abnormal placental site (placenta previa)

Exclusion Criteria:

- refusal to participate in the study

- cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Trans- abdominal sonography

• Trans-vaginal sonography

Procedure:
• post-operative pathological specimen examination

Locations
Country Name City State
Egypt Kasr el aini hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary intraoperative blood loss 24 hours Yes