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

First Trimester Pregnancy Clinical Trial

— IMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01988740
• Other study ID #: 2013/87
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2013
• Last updated: November 14, 2013
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: November 2013
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: hediye dagdeviren, md
• Phone: 5079872463
• Email: hediyedagdeviren[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first trimester pregnant women	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	No