Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

First Trimester Pregnancy Fetal Heart Activity Absent Absence of Fetal Pole on Ultrasonographic Examination.

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ischemia-modified albumin Recurrent pregnancy loss Abnormal placenta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hediye Dagdeviren

md

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

hüseyin cengiz, md

Role: STUDY_DIRECTOR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

hediye dağdeviren, md

Role: CONTACT

Phone: 5079872463

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

hediye dagdeviren, md

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Cengiz H, Dagdeviren H, Kanawati A, Suzen Caypinar S, Yesil A, Ekin M, Yasar L. Ischemia-modified albumin as an oxidative stress biomarker in early pregnancy loss. J Matern Fetal Neonatal Med. 2016;29(11):1754-7. doi: 10.3109/14767058.2015.1061494. Epub 2015 Jul 2.

Reference Type DERIVED

PMID: 26135770 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013/87

Identifier Type: -

Identifier Source: org_study_id