- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988740
Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin (IMA)
November 14, 2013 updated by: Hediye Dagdeviren, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
The finding that ischemia-modified albumin (IMA) is increased in pre-eclamptic pregnancy suggests a role for IMA as a potential biomarker for abnormal placental development related to miscarriage.This study was undertaken to evaluate IMA levels in women with recurrent pregnancy loss (RPL).
Study Overview
Status
Unknown
Detailed Description
Ischemia-modified albumin (IMA) measured by the albumin cobalt binding test is a relatively new biomarker in the identification of myocardial ischemia.
Experimental studies have shown that pregnancies normally develop in a relatively hypoxic intrauterine environment, and the subsequent reperfusion and oxidative stress is important for physiological trophoblast development.
The finding that maternal serum IMA levels are raised so early in pregnancy provides further support for IMA as a potential marker for abnormal placental development that may be related to early pregnancy loss.
In this study, we aimed to evaluate maternal circulating IMA levels in women with RPL by comparing them with healthy controls.
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34140
- Recruiting
- Bakirkoy Dr Sadi Konuk Training and Research Hospital
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
first trimester pregnancy with absence of fetal cardiac activity
Description
Inclusion Criteria:
- first trimester pregnancy
- absence of fetal cardiac activity
- absence of fetal pole
- history of two or more unexplained first trimester miscarriages
- no live births
- apparently healthy women attending for antenatal care in the first trimester with at least one previous uneventful natural pregnancy
Exclusion Criteria:
- pre-existing diabetes or vascular disease were excluded
- diagnosis of chromosomal, anatomic, endocrinologic and autoimmunologic etiology of recurrent pregnancy loss
- Women with multiple pregnancy
- any major or minor fetal anomaly
- current smokers
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
first trimester pregnant women
Time Frame: under 14 w gestation
|
first trimester pregnancy with absence of fetal cardiac activity or absence of fetal pole on ultrasonographic examination Patients with a history of two or more unexplained first trimester miscarriages and no live births were included in the study.
|
under 14 w gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2013
Primary Completion (Anticipated)
March 1, 2014
Study Completion (Anticipated)
April 1, 2014
Study Registration Dates
First Submitted
November 14, 2013
First Submitted That Met QC Criteria
November 14, 2013
First Posted (Estimate)
November 20, 2013
Study Record Updates
Last Update Posted (Estimate)
November 20, 2013
Last Update Submitted That Met QC Criteria
November 14, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/87
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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