First Trimester PregnancyIMANCT01988740
Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin
An observational study of First Trimester Pregnancy and Fetal Heart Activity Absent, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- First Trimester Pregnancy, Fetal Heart Activity Absent, Absence of Fetal Pole on Ultrasonographic Examination.
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: first trimester pregnancy with absence of fetal cardiac activity
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34140
hediye dagdeviren, md, 5079872463, hediyedagdeviren@gmail.com
About this study
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.
- Conditions
- First Trimester Pregnancy, Fetal Heart Activity Absent, Absence of Fetal Pole on Ultrasonographic Examination.
- Keywords
- Ischemia-modified albumin, Recurrent pregnancy loss, Abnormal placenta
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: under 14 w gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Trimester PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hediye Dagdeviren, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- hüseyin cengiz, md, Study director, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988740
- Sponsor's protocol ID
- 2013/87
- Acronym
- IMA
- Status last verified
- Nov 2013
- First submitted
- 14 Nov 2013
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin
- ClinicalTrials.gov ID
- NCT01988740
- Acronym / sponsor ID
- IMA / 2013/87
- Conditions
- First Trimester Pregnancy, Fetal Heart Activity Absent, Absence of Fetal Pole on Ultrasonographic Examination.
- Keywords
- Ischemia-modified albumin, Recurrent pregnancy loss, Abnormal placenta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- first trimester pregnancy with absence of fetal cardiac activity
Key inclusion criteria (6 listed)
- first trimester pregnancy
- absence of fetal cardiac activity
- absence of fetal pole
- history of two or more unexplained first trimester miscarriages
- no live births
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
first trimester pregnant women
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Derived from this study: PubMed 26135770Cengiz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hüseyin cengiz, md study director
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Trimester Pregnancy and Fetal Heart Activity Absent, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hediye dağdeviren, md (5079872463, hediyedagdeviren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first trimester pregnant women (time frame: under 14 w gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.