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

• Conditions: First Trimester Pregnancy; Fetal Heart Activity Absent; Absence of Fetal Pole on Ultrasonographic Examination.

• Registration Number: NCT01988740
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-14
• Last Update Submitted: 2013-11-14
• Study First Posted: 2013-11-20
• Last Update Posted: 2013-11-20
• Primary Completion: 2014-03
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
first trimester pregnant women	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.

Trial Locations

Locations (1)

Bakirkoy Dr Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey