PreeclampsiaNCT03088228
Maternal Periodontal Status and Cytokines in Preeclampsia
An observational study of Preeclampsia and Periodontal Diseases, run by Hacer Sahin Aydinyurt.
Trial summary
Background: The purpose of this study is to examine the relationship between maternal preeclampsia and periodontal parameters and the correlation of these two disorders with maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and interleukin-6. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia, Periodontal Diseases
- What is being tested?
- gingival crevicular fluid collection
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 31 Dec 2016
- How long will I take part?
- 6 Months
- 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 18 to 45 years
- Women only
- Adult
Study population: 23 severe preeclamptic patient, 30 mild preeclamptic patient and 29 healthy pregnant women were recruited to this study.
Who may be able to join
- Aged between 18 and 45 years
- 25 and 40 weeks of gestation.
- Healthy pregnants, mild and severe preeclampsia
Who cannot join
- Patients with accompanying diseases
- multiple gestations
- congenital abnormalities were excluded from the study.
About this study
Official title: Maternal Periodontal Status and Gingival Crevicular Fluid Levels of Interleukin-6, Interleukin-35, and Interleukin-37 in Preeclampsia
Background: The purpose of this study is to examine the relationship between maternal preeclampsia and periodontal parameters and the correlation of these two disorders with maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and interleukin-6. The investigators also investigated their relation to the severity of preeclampsia.
Methods: 82 preeclamptic women were recruited to the study (29 healthy pregnant women, 30 mild preeclamptic patient, 23 severe preeclamptic patient ). The clinical periodontal parameters and GCF samples were collected in the first day of puerperium.
- Conditions
- Preeclampsia, Periodontal Diseases
- Being tested
- gingival crevicular fluid collection
- Medical subject headings
- Pre-Eclampsia, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival crevicular fluid collectionDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnants | Not described Receives: Diagnostic Test: gingival crevicular fluid collection | |
| mild preeclampsia | Not described | |
| severe preeclampsia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal periodontal clinical parameters and IL-37 and IL-35 and IL-6 levels
IL-37 IL-35 and IL-6 levels in maternal gingival crevicular fluid levels between the three groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start2 Feb 2015
- Primary completion15 Aug 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Other
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hacer Sahin Aydinyurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hacer Sahin Aydinyurt, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088228
- Sponsor's protocol ID
- 2015-HIZ-DF306
- Status last verified
- Sep 2017
- First submitted
- 16 Feb 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Periodontal Status and Gingival Crevicular Fluid Levels of Interleukin-6, Interleukin-35, and Interleukin-37 in Preeclampsia
- ClinicalTrials.gov ID
- NCT03088228
- Acronym / sponsor ID
- 2015-HIZ-DF306
- Conditions
- Preeclampsia, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacer Sahin AydinyurtUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 23 Mar 2017 (actual)
- 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.
Background: The purpose of this study is to examine the relationship between maternal preeclampsia and periodontal parameters and the correlation of these two disorders with maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and interleukin-6. The investigators also investigated their relation to the severity of preeclampsia.
Methods: 82 preeclamptic women were recruited to the study (29 healthy pregnant women, 30 mild preeclamptic patient, 23 severe preeclamptic patient ). The clinical periodontal parameters and GCF samples were collected in the first day of puerperium.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy pregnants | – | Diagnostic Test: gingival crevicular fluid collection |
| mild preeclampsia | – | – |
| severe preeclampsia | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 23 severe preeclamptic patient, 30 mild preeclamptic patient and 29 healthy pregnant women were recruited to this study.
Key inclusion criteria (3 listed)
- Aged between 18 and 45 years
- 25 and 40 weeks of gestation.
- Healthy pregnants, mild and severe preeclampsia
Key exclusion criteria (3 listed)
- Patients with accompanying diseases
- multiple gestations
- congenital abnormalities were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gingival crevicular fluid collection | Diagnostic test | healthy pregnants |
Primary outcome
maternal periodontal clinical parameters and IL-37 and IL-35 and IL-6 levels
Time frame: 6 months
IL-37 IL-35 and IL-6 levels in maternal gingival crevicular fluid levels between the three groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Periodontal Diseases, run by Hacer Sahin Aydinyurt.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal periodontal clinical parameters and IL-37 and IL-35 and IL-6 levels (time frame: 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 28 Sep 2017.