A Study Looking at Women's Experiences After a Miscarriage

December 16, 2010 updated by: California State University, Stanislaus

An Investigation of Women's Experiences Following Karyotyping Products of Conception After a Miscarriage

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Http://Www.Surveymonkey.Com/S/Miscarriagestudy3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The investigators are targeting woman based on the inclusion and exclusion criteria provided below.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California State University, Stanislaus

Collaborators

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimate)

October 19, 2010

Study Record Updates

Last Update Posted (Estimate)

December 17, 2010

Last Update Submitted That Met QC Criteria

December 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1011-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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