NCT01223482

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 17, 2010

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

October 18, 2010

Last Update Submit

December 16, 2010

Conditions

Keywords

MiscarriageKaryotypingGenetic testing

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Http://Www.Surveymonkey.Com/S/Miscarriagestudy3

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Diem T Huynh, B.S.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

December 17, 2010

Record last verified: 2010-09

Locations