Placenta PreviaNCT02270593
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis (Accreta, Increta, Percreta).
An observational study of Placenta Previa, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the oxidant / antioxidant enzyme levels. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Oct 2015
- How long will I take part?
- 2 Years
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: tertiary health institutions
Who may be able to join
- pregnant women diagnosed with placenta previa by obstetric ultrasound and doppler
Who cannot join
- Pregnant women with comorbid diseases other than previa totalis .
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Women's Health Education and Research Hospital
Ankara
SİBEL ÖZLER, MD, 0(312)30650000
AHMET NURİ DANIŞMAN, MD
About this study
Official title: ADAMTS, Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis(Accreta, Increta, Percreta)
Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the oxidant / antioxidant enzyme levels.
Read the detailed description
Placenta previa totalis (accreta, increta, percreta) of pregnant women in the maternal serum, fetal membranes (placenta) and hysterectomy of women with myometrial strips measured the ADAMTS and proteoglycans expression levels, and the oxidant / antioxidant enzyme levels.
- Conditions
- Placenta Previa
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Placenta previa | first; maternal serum, fetal membranes (placenta) and maternal myometrial samples will be investigated for ADAMTS, Proteoglycans and oxidative/antioxidative enzyme status levels in patients with placental invasion anomalies Placenta Previa totalis by ELISA, western blot, immunohystochemistry and PCR (polymerase chain reaction). |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of maternal serum in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
Measured: Up to 6 months
Secondary outcomes (3)
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of myometrial samples in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
Measured: Up to 6 months
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Fetal Membranes in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
Measured: Up to 6 months
placenta previa totalis in the development, progression and in exacerbating; ADAMTS and proteoglycans, to determine the relationship of changes in expression.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sibel özler, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- ahmet nuri danısman, md, Study director, zekai tahir burak women's health education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270593
- Sponsor's protocol ID
- prospective study-2
- Status last verified
- Oct 2014
- First submitted
- 22 Aug 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAMTS, Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Placenta Previa Totalis(Accreta, Increta, Percreta)
- ClinicalTrials.gov ID
- NCT02270593
- Acronym / sponsor ID
- prospective study-2
- Conditions
- Placenta Previa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 21 Oct 2014 (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.
Placenta previa totalis (accreta, increta, percreta); ADAMTS and proteoglycans and the oxidant / antioxidant enzyme levels.
Detailed description
Placenta previa totalis (accreta, increta, percreta) of pregnant women in the maternal serum, fetal membranes (placenta) and hysterectomy of women with myometrial strips measured the ADAMTS and proteoglycans expression levels, and the oxidant / antioxidant enzyme levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placenta previa | – | –first; maternal serum, fetal membranes (placenta) and maternal myometrial samples will be investigated for ADAMTS, Proteoglycans and oxidative/antioxidative enzyme status levels in patients with placental invasion anomalies Placenta Previa totalis by ELISA, western blot, immunohystochemistry and PCR (polymerase chain reaction). |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- tertiary health institutions
Key inclusion criteria (1 listed)
- pregnant women diagnosed with placenta previa by obstetric ultrasound and doppler
Key exclusion criteria (1 listed)
- Pregnant women with comorbid diseases other than previa totalis .
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
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of maternal serum in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
Time frame: Up to 6 months
3 secondary outcomes
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of myometrial samples in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
Time frame: Up to 6 months
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of Fetal Membranes in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta)
Time frame: Up to 6 months
placenta previa totalis in the development, progression and in exacerbating; ADAMTS and proteoglycans, to determine the relationship of changes in expression.
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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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.
ahmet nuri danısman, md study director
zekai tahir burak women's health education and research 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 Placenta Previa, run by Zekai Tahir Burak Women's Health Research and Education 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 1 inclusion and 1 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 21 Oct 2014. 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 sibel özler, md (05457970257, sibelozler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAMTS,Proteoglycan and Oxidant / Antioxidant Enzyme Levels of maternal serum in patients with the diagnosis of Placenta Previa (Accreta, increta, percreta) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2014.