Detection of Risk Factors for Fetal Anomalies in a Rural Hospital Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01662596
First received: August 7, 2012
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition
Pregnancy
Pregnancy Complications

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Detection of Risk Factors for Fetal Anomalies in a Rural Hospital Population

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment: 320
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Major defects prevalence in the general population is estimated at 5% of all live births. In cases where the fetus suffers from structural defect, chromosomal or genetic disease, prenatal diagnosis is an important scientific tool that allows reliable advice and better pregnancy outcomes.

Diseases and many embryonic defects can be detected early, including nervous system defects, heart defects, urinary tract defects, limb defects and more. Taking folic acid before pregnancy and during the first trimester reduces the incidence of some of these defects.

Aneuploidy and mainly trisomy 21,18,13, Monosomy X and aneuploid in sex chromosome is responsible for most of the chromosomal anomalies. Some of aneuploidy can be diagnosed by a combination of nuchal translucency (also associated with cardiac abnormalities) and maternal serum markers detection in the first trimester of pregnancy or a laboratory test in the second trimester. Ultrasound is also a tool for diagnosis of aneuploidity, which detecting abnormalities characteristic or "soft signs" who suspicious in chromosomal disorder.

Genetic tests is another diagnostic tool that suggested to general population and in individual cases adapted to genetic diseases that are known.

In 2008 about 75.5% of the population in Israel were Jews, 20.2% Arabs, and 4.3 were defined as "others". Approximately 45% of Arabs living in the northern region compared to 10% of the Jewish population. Congenital malformations were the leading cause of death in infants Arab and the second cause of death in Jewish infants.

In recent years the supply of screening before and during pregnancy has increased, but it is apparent that the rate of implementation of nuchal translucency, amniocentesis and therefore detection of disease are lower in Arab population, as well as the rates of taking folic acid. These differences between populations in carrying out tests that enable prevention and early detection of birth defects and neonatal genetic diseases also associated with differences in economic, religious and age of the woman.

In this work we try to know the population applying for medical services at Hillel Yaffe Hospital. 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.

We hypothesize that a large percentage of the population who turn to Hillel Yaffe Hospital has risk factors for having a sick fetus and the Muslim population is in higher risk than the Jewish population.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women in the first trimester Pregnant women who doesn't want to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662596

Contacts
Contact: Yael Yagur, student 972-52-3309429 yaelyagur@gmail.com
Contact: Alon Shrim, M.D.

Locations
Israel
Obstetric and Gynaecology Department Not yet recruiting
Hadera, Israel
Principal Investigator: yael yagur, student         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: yael yagur, student Technion, Israel Institute of Technology
Study Director: Alon Shrin, M.D. Ultrasound unit manager, obstetric and gynaecology, Hillel Yaffe
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01662596     History of Changes
Other Study ID Numbers: 0044-12-HYMC
Study First Received: August 7, 2012
Last Updated: August 8, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Risk factors,
prenatal diagnosis,
fetal malformations

Additional relevant MeSH terms:
Pregnancy Complications
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014