CClinicalTrials.gg
Status unknownNCT01988740IMAUpdated Nov 20, 2013

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

An observational study in First Trimester Pregnancy, Fetal Heart Activity Absent and Absence of Fetal Pole on Ultrasonographic Examination., sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Status unknown at 1 site in Turkey. Open to female participants. Per ClinicalTrials.gov, last updated 2013-11-20.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
180
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

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

Keywords

  • Ischemia-modified albumin
  • Recurrent pregnancy loss
  • Abnormal placenta
03

In context

Abortion, Spontaneous

320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.

This study's planned enrollment of 180 is close to the median of 200 across 140 observational studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

first trimester pregnancy with absence of fetal cardiac activity

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
180 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: under 14 w gestation

07

Study locations

1 of 1 sites recruiting
  • Bakirkoy Dr Sadi Konuk Training and Research Hospital
    Istanbul, 34140, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26135770 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01988740
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible party
Hediye Dagdeviren (md, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Principal investigator
First posted
Nov 20, 2013
Start date
Nov 2013
Primary completion
Mar 2014 (estimated)
Completion
Apr 2014 (estimated)
Last update
Nov 20, 2013

Study contacts

hediye dağdeviren, md
Contact
hediyedagdeviren@gmail.com
5079872463
hüseyin cengiz, md
study director · Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion