Maternal Serum Alpha-fetoprotein Level May Predict the Pr... | NCT04082507

Studies
Maternal Serum Alpha-fetoprotein Level May Predict the Presence of Morbid Adherent Placenta

NCT04082507

Sponsor

rasha medhat abdul-hady

Status

Unknown status

Last Update Posted

Sep 9, 2019Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Placenta Accreta

Interventions

Serum alpha-fetoproteine

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Aug 30, 2019Estimated

Completion Date

Aug 30, 2019Estimated

First Submitted Date

Aug 29, 2019

First Submission Date that Met QC Criteria

Sep 6, 2019

First Posted Date

Sep 9, 2019Actual

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 6, 2019

Last Update Posted Date

Sep 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

rasha medhat abdul-hady, Lecturer of obstetrics and gynecology, Ain Shams UniversitySponsor-Investigator

Lead Sponsor

rasha medhat abdul-hadyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta.

Detailed Description

in pregnant women withe previous cesarean section, placenta previa and ultrasonographic finding of an abnormally adherent placenta dose maternal serum alpha-fetoprotein predict prenataly the presence of morbid adherent placenta accurately?

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non_adherent plcenta		placenta separated within 15 minutes after delivery of fetus
Adherent placenta		placenta dosenot separated within 15 minutes after delivery of fetus	Diagnostic Test: Serum alpha-fetoproteine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum alpha-fetoproteine	Diagnostic Test	Midtrimesteric serum alpha-fetoprotein mesurment with 2D US and 3D power Doppler with MS US scan .	Adherent placenta

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal serum alpha-fetoprotein	ng/ml or MOM(Multiple of the median)	From 28weeks to 37 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women with history of scarred uterus
- plcenta previa covering the scar of previous caesarean section as diagnosed by 2DU/S
- Gestational age from 28wks to full term

Exclusion Criteria:

pregnant women with fetus with congenital anomalies
- pregnant women with ovarian swelling
- pregnant women with medical disease

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

150 pregnant women from 28wk to full term who are attending outpatient clinic and emergency room ain shams university maternal hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university maternity hospital		Cairo			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