NCT01662596

Brief Summary

The purpose of the study is to estimate the rate of risk factors for appearance of disease or fetal malformations in a population who turn to hospital "Hillel Yaffe" and examine whether there is a difference in the rate of early testing for diseases or birth defects in the fetus. Understanding the population and its risk factors, will allow specific reference to these risk factors to lowering them to eventually reduce the rate of congenital malformations in this population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

1 month

First QC Date

August 7, 2012

Last Update Submit

August 8, 2012

Conditions

PregnancyPregnancy Complications

Keywords

Risk factors,prenatal diagnosis,fetal malformations

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women who address the emergency room, Ultrasound unit or foreign clinics.

You may qualify if:

  • Pregnant women who address the emergency room, Ultrasound unit or foreign clinics in the second or third trimester.

You may not qualify if:

  • Pregnant women in the first trimester Pregnant women who doesn't want to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetric and Gynaecology Department

Hadera, Israel

Location

MeSH Terms

Conditions

Pregnancy ComplicationsCongenital Abnormalities

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • yael yagur, student

    Technion, Israel Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Alon Shrin, M.D.

    Ultrasound unit manager, obstetric and gynaecology, Hillel Yaffe

    STUDY DIRECTOR

Central Study Contacts

Yael Yagur, student

CONTACT

972-52-3309429yaelyagur@gmail.com

Alon Shrim, M.D.

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 10, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2012

Study Completion

August 1, 2013

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

IL(1)