Fetal Viability Estimation in Egypt | NCT02120378

Studies
Fetal Viability Estimation in Egypt

NCT02120378

Sponsor

Woman's Health University Hospital, Egypt

Status

Unknown status

Last Update Posted

Mar 31, 2015Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Premature Birth
Miscarriage

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

Mar 2015

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

Apr 2014

Primary Completion Date

Aug 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Apr 17, 2014

First Submission Date that Met QC Criteria

Apr 17, 2014

First Posted Date

Apr 22, 2014Estimated

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

Mar 27, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dina Mohamed Refaat Dakhly, MD, Cairo UniversityPrincipal Investigator

Lead Sponsor

Woman's Health University Hospital, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or live birth, there seemed to be a need for a study that ends up with reaching a definition for the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight more than 500 grams, while in Egypt, this is not applicable. basically the neonate has a chance of survival if the weight is more than 1000 grams or of gestational age more than 26 weeks.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
determination of age of fetal viability according the survival rate percentage		1 year

Secondary Outcomes

Measure	Description	Time Frame
most common causes for premature delivery in Egypt		6 months
the mode of delivery of preterm cases in Egypt		10 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant females age from 18- 40 years old
preterm delivery before completing 38 weeks of gestation
singleton or multiple gestation
fetuses with congenital anomalies

Exclusion Criteria:

refusal to get enrolled in the study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

females presenting to the causality department in kasr el Aini hospital presenting with signs of preterm labor ( uterine contractions before completing 38 weeks of gestation)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
dina m dakhly, MD	Contact	201003498919		dinadakhly@gmail.com

Overall Officials

Name	Affiliation	Role
dina m dakhly, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr El Aini	Recruiting	Cairo	Cairo Governorate	12211	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D000022	Abortion, Spontaneous

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided