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

NCT01988740 | Unknown

• 1 other identifier: 2013/87
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Ischemia-modified albumin; Recurrent pregnancy loss; Abnormal placenta

Outcome Measures

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.

  under 14 w gestation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

first trimester pregnancy with absence of fetal cardiac activity

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, 34140, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 26135770 DERIVED

Study Officials

• hüseyin cengiz, md

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

hediye dağdeviren, md

CONTACT

5079872463; hediyedagdeviren@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

TU (1)