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Management of Placenta Accreta Spectrum

Primary Purpose

Placenta Previa, Placenta Accreta

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Management of placenta accreta spectrum
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Placenta Previa focused on measuring placenta, accreta, praevia, hyterectomy, PPH

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All placenta accreta e high possibility of placenta accrete
  • consent
  • easy follow up visits

Exclusion Criteria:

  • bleeding tendency
  • associated medical disorder hypertension, diabetes, preeclapsia..

Sites / Locations

  • Osama AbdalmageedRecruiting
  • Assiut UniversityRecruiting

Outcomes

Primary Outcome Measures

Failure of the novel conservative management
Need to do peripartum hysterectomy or patient death
Estimated amount of blood loss
The estimated amount of blood loss during and after surgery

Secondary Outcome Measures

Full Information

First Posted
October 15, 2020
Last Updated
October 30, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04609527
Brief Title
Management of Placenta Accreta Spectrum
Official Title
Management of Placenta Accreta Spectrum
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.
Detailed Description
placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it. surgical management of placenta accreta short term follow up to the outcomes long term follow up

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa, Placenta Accreta
Keywords
placenta, accreta, praevia, hyterectomy, PPH

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All women with placenta praevia and previous scar in the uterus. Surgical management and follow up will be defined
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Management of placenta accreta spectrum
Intervention Description
Conservative and radical (hysterectomy) treatment of placenta accreta. Follow up to the patients to detect the impact of treatment imposed A novel technique which early identification and repait of uterine wall defects resulted from invasion of the uterine wall by the placenta.
Primary Outcome Measure Information:
Title
Failure of the novel conservative management
Description
Need to do peripartum hysterectomy or patient death
Time Frame
3 hours
Title
Estimated amount of blood loss
Description
The estimated amount of blood loss during and after surgery
Time Frame
6 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All placenta accreta e high possibility of placenta accrete consent easy follow up visits Exclusion Criteria: bleeding tendency associated medical disorder hypertension, diabetes, preeclapsia..
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama Abdalmageed
Phone
01012234876
Email
drosamast@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
maha said
Phone
01013464458
Email
drmahasaid2014@gmail.com
Facility Information:
Facility Name
Osama Abdalmageed
City
Assiut
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama Abdalmageed
Phone
1007972027
Email
drosamast1981@gmail.com
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdalmageed
Phone
1007972027
Email
drosamast@yahoo.com.au

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Management of Placenta Accreta Spectrum

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