Descriptive Study of the Incidence and Outcome of PAS in... | NCT05636865

Studies
Descriptive Study of the Incidence and Outcome of PAS in Two Large Referral Hospitals in Egypt

NCT05636865

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Dec 5, 2022Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Placenta Accreta

Interventions

Not provided

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

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2022Actual

Primary Completion Date

Nov 10, 2022Actual

Completion Date

Mar 30, 2023Estimated

First Submitted Date

Nov 13, 2022

First Submission Date that Met QC Criteria

Nov 24, 2022

First Posted Date

Dec 5, 2022Actual

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

Nov 24, 2022

Last Update Posted Date

Dec 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rihab Hagag Sayed, resident doctor , principle investigator, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

placenta accreta spectrum incidence and outcome

Detailed Description

placenta accreta spectrum ( PAS ) one of the most serious condition in obstetrics nowadays so the investigators measure the incidence by this study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of diagnosed pregnant women with placenta accreta spectrum	pregnant women with gestitional age above 18 week , with confirmed diagnosis with PAS with U/S	in last 6 years

Secondary Outcomes

Measure	Description	Time Frame
incidence of hystrectomy	hystrectomy VS conservative management	in last 6 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gestational age above 28 weeks

Exclusion Criteria:

age less than 18

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

pregnant woman above 28 weeks

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
rihab hagag, resident	kasr alainy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy , Cairo University		Cairo		002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

incidence of PAS

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010921	Placenta Accreta

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided