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NCT02120378 Clinical Trial

Fetal Viability Estimation in Egypt

Premature Birth Clinical Trial

Official title:
Correlation Between Fetal Gestational Age, Viability and Survival Rates in Egypt

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02120378
Other study ID # WH142014
Secondary ID
Status Recruiting
Phase N/A
First received April 17, 2014
Last updated March 27, 2015
Start date April 2014
Est. completion date September 2015

Study information
Verified date March 2015
Source Woman's Health University Hospital, Egypt
Contact dina m dakhly, MD
Phone 201003498919
Email dinadakhly@gmail.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date September 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt Kasr El Aini Cairo

Sponsors (1)
Lead Sponsor Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary determination of age of fetal viability according the survival rate percentage 1 year No
Secondary most common causes for premature delivery in Egypt 6 months No
Secondary the mode of delivery of preterm cases in Egypt 10 months No
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