Clincosm LogoSign in Get a demo

A Study Looking at Women's Experiences After a Miscarriage

Sponsor
California State University, Stanislaus (Other)
Overall Status
Unknown status
CT.gov ID
NCT01223482
Collaborator
Stanford University (Other)
400
Enrollment
1
Location
8
Duration (Months)
50.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Oct 1, 2010
    Anticipated Primary Completion Date :
    Feb 1, 2011
    Anticipated Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Http://Www.Surveymonkey.Com/S/Miscarriagestudy3 Palo Alto California United States 94303

      Sponsors and Collaborators

      • California State University, Stanislaus
      • Stanford University

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01223482
      Other Study ID Numbers:
      • 1011-017
      First Posted:
      Oct 19, 2010
      Last Update Posted:
      Dec 17, 2010
      Last Verified:
      Sep 1, 2010
      Keywords provided by , ,
      Miscarriage
      Karyotyping
      Genetic testing
      Additional relevant MeSH terms:
      Abortion, Spontaneous

      Study Results

      No Results Posted as of Dec 17, 2010