Surgical Classification of Abnormal Placentation | NCT02736058

Studies
Surgical Classification of Abnormal Placentation

NCT02736058

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 1, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Adherent Placenta

Interventions

Trans- abdominal sonography
Trans-vaginal sonography
post-operative pathological specimen examination

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 22, 2016

First Submission Date that Met QC Criteria

Apr 7, 2016

First Posted Date

Apr 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2016

Last Update Posted Date

Jun 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Mahmoud Hussein, Lecturer of Obstetrics and Gynecology, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants	Experimental	the included pregnant females will undergo trans-abdominal sonography as well as trans-vaginal sonography , to diagnose the abnormal placentation and the results will be compared to the intra- operative as well as the pathological examination of the specimen.	Device: Trans- abdominal sonography Device: Trans-vaginal sonography Procedure: post-operative pathological specimen examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trans- abdominal sonography	Device		Participants
Trans-vaginal sonography

Measure	Description	Time Frame
intraoperative blood loss		24 hours

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed M Hussein, MD	Contact	01223515652	002	ahmed_mhussein@live.com
Dina M Dakhly, MD	Contact	01003498919	002	dinadakhly@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed M Hussein, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr el aini hospital	Recruiting	Cairo	Cairo Governorate	12211	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided