Role of Ultrasound in Diagnosis of Placenta Previa and MAP | NCT03416296

Studies
Role of Ultrasound in Diagnosis of Placenta Previa and MAP

NCT03416296

Sponsor

Aljazeera Hospital

Status

Completed

Last Update Posted

Sep 16, 2021Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Morbidly Adherent Placenta

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

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2018Actual

Primary Completion Date

Jun 10, 2019Actual

Completion Date

Dec 20, 2019Actual

First Submitted Date

Jan 24, 2018

First Submission Date that Met QC Criteria

Jan 24, 2018

First Posted Date

Jan 31, 2018Actual

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

Sep 15, 2021

Last Update Posted Date

Sep 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera HospitalPrincipal Investigator

Lead Sponsor

Aljazeera HospitalOTHER

Collaborators

Name	Class
Cairo University	OTHER
National Research Centre, Egypt	OTHER

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 occurs when the placental implantation is abnormal. The marked rise in incidence has been assumed the increasing prevalence of cesarean delivery in recent years.

Detailed Description

The most accepted theory is that abnormal placentation . The most important risk factor for placenta accreta is placenta previa after a prior cesarean delivery. The first clinical manifestation of placenta accreta is usually severe , life-threatening hemorrhage. The recommended intervention of suspected placenta accreta is planned preterm cesarean hysterectomy with the placenta left in situ.

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

Retention

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal placenta		TA , TV ,TP us
placenta previa and MAP		TA,TV.TP us

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participants who will be diagnosed to have normal placenta or placenta previa or morbidly adherent placenta by US		within 6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant ladies with previous cesarean sections
GA above 30 weeks

Exclusion Criteria:

Primigravida patients
GA below 30 weeks

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant females with GA above 30 weeks

Minimum Age

20 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

pregnant females with previous cs will be subjected to US to assess placental location and MAP

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy	Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah		Giza			Egypt

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