MiscarriageNCT01223482
A Study Looking at Women's Experiences After a Miscarriage
An observational study of Miscarriage, run by California State University, Stanislaus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Miscarriage
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators are targeting woman based on the inclusion and exclusion criteria provided below.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Http://Www.Surveymonkey.Com/S/Miscarriagestudy3
Palo Alto, California, 94303
About this study
Official title: 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.
- Conditions
- Miscarriage
- Keywords
- Miscarriage, Karyotyping, Genetic testing
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, Stanislaus
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223482
- Sponsor's protocol ID
- 1011-017
- Status last verified
- Sep 2010
- First submitted
- 18 Oct 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Women's Experiences Following Karyotyping Products of Conception After a Miscarriage
- ClinicalTrials.gov ID
- NCT01223482
- Acronym / sponsor ID
- 1011-017
- Conditions
- Miscarriage
- Keywords
- Miscarriage, Karyotyping, Genetic testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- California State University, StanislausUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators are targeting woman based on the inclusion and exclusion criteria provided below.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage, run by California State University, Stanislaus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diem T Huynh, B.S. (650-483-5827, diem218@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.