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A Study Looking at Women's Experiences After a Miscarriage

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ClinicalTrials.gov Identifier: NCT01223482
Recruitment Status : Unknown
Verified September 2010 by California State University, Stanislaus.
Recruitment status was:  Recruiting
First Posted : October 19, 2010
Last Update Posted : December 17, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Studies have shown that a majority of pregnancies that end in miscarriage are due to a chromosome abnormality usually involving a duplicated or missing chromosome. Often this happens by chance and is not likely to occur in future pregnancies. For many women, a miscarriage can be a traumatic experience and can cause feelings of loss and grief. The option of genetic testing, such as karyotyping, may offer an explanation for the miscarriage and may help some women find closure in their loss. However, no literature exists on a women's experience with genetic testing following a miscarriage. This assumption that the knowledge that can be gained from karyotyping may be a positive experience for a woman following a miscarriage should be studied and the results published. This study will address whether routine karyotyping should be offered following a miscarriage for the purpose of benefiting the patient's experience.

Condition or disease
Miscarriage

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Investigation of Women's Experiences Following Karyotyping Products of Conception After a Miscarriage
Study Start Date : October 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Miscarriage with genetic testing
This is a study population of women that have had a miscarriage and had genetic testing performed. The investigators would like to know what their experiences were following their miscarriage and testing.
Miscarriage without genetic testing
This cohort is considered the control group. These women have not had genetic testing done, but are asked questions regarding their miscarriage experience.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The investigators are targeting woman based on the inclusion and exclusion criteria provided below.
Criteria

Inclusion Criteria:

  • The inclusion criteria for this project will be females, 18 years or older, of any ethnicity that have had a 1st trimester miscarriage within the last one year, who currently reside in the US and have done so for the past one year.

Exclusion Criteria:

  • Exclusion criteria will be males, females younger than 18 years of age, females with a miscarriage over one year, non-US residents and US residents where the miscarriage occurred outside of the US.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223482


Contacts
Contact: Diem T Huynh, B.S. 650-483-5827 diem218@gmail.com

Locations
United States, California
Http://Www.Surveymonkey.Com/S/Miscarriagestudy3 Recruiting
Palo Alto, California, United States, 94303
Sponsors and Collaborators
California State University, Stanislaus
Stanford University
More Information

Responsible Party: Janey Youngblom, CSU Stanislaus
ClinicalTrials.gov Identifier: NCT01223482     History of Changes
Other Study ID Numbers: 1011-017
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: September 2010

Keywords provided by California State University, Stanislaus:
Miscarriage
Karyotyping
Genetic testing

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications