Preterm LaborNCT03610841
Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor
An observational study of Preterm Labor and Periodontal Disease, run by Recep Tayyip Erdogan University Training and Research Hospital at 6 sites in 2 countries.
Trial summary
The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor. The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods. Read more about this study
- Who is it for?
- Ages 21 to 34 years, women only
- Conditions the study is for
- Preterm Labor, Periodontal Disease
- What is being tested?
- preterm labor and healthy
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 17 Feb 2018to 15 Dec 2018
- 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 21 to 34 years
- Women only
- Adult
Study population: The study is planned to be a case-control study. Workgroup consists of 50 patients which diagnosed with preterm labor between the age of 21 and 34. Control group consists of healthy females 24-36 6/7 weeks of pregnant with no history of preterm labor.
Who may be able to join
- pregnant women with preterm labor
- 37. weeks of pregnant women with no history of preterm labor
Who cannot join
- Genitourinary infection
- pregnancy or pre-pregnancy hypertension
- HIV infection
- diabetes mellitus
- multiple pregnancy, preterm labor / low birth weight
- smoker and alcohol use history
Show all 14Show fewer
- IVF pregnancy
- placental, cervical and uterine anomalies
- pregnancy with intrauterine growth retardation
- pregnancies with congenital or chromosomal fetal anomalies
- significant vaginal bleeding
- infertility stories
- drug addicts
- poor socioeconomic level
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Turkey (Türkiye)5 sites, 2 recruiting
- Recruiting
Ege University Dentistry Faculty
Izmir
: Nurcan Buduneli, Prof. Dr., 05326962525, nurcanbuduneli@yahoo.com
Önder Gürlek, Dr., 05057555888, dr.ondergurlek@hotmail.com
- Recruiting
İzmir Health Sciences University, Tepecik Training and Research Hospital Department of Obstetrics and Gynecology
Izmir
Murat Alan, Dr., 05333952097, gozdealan@hotmail.com
- Active, not recruiting
Recep Tayyip Erdogan University Dentistry Faculty
Rize, 53000
- Active, not recruiting
Recep Tayyip Erdogan University Faculty of Medicine
Rize, 53000
- Active, not recruiting
Recep Tayyip Erdogan University
Rize, 53000
United Kingdom1 site
- Active, not recruiting
Glaskow Dental School , School of Medicine University of Glasgow
Glaskow
About this study
Official title: Evaluation of the Possible Relationship Between Preterm Labor and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data
The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor.
The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.
Read the detailed description
Preterm infants are born prior to completion of 37 weeks of gestation. Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preterm labor. It is believed that the results will set light to the etiology of preterm labor and will help to develop strategies to prevent the disease.
- Conditions
- Preterm Labor, Periodontal Disease
- Being tested
- preterm labor, healthy
- Medical subject headings
- Obstetric Labor, Premature, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preterm laborDiagnostic test
Also called blood sample, urine test
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
healthyDiagnostic test
Also called blood sample, urine test
liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
| Study group | Role | What they receive |
|---|---|---|
| preterm labor | Workgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34 Receives: Diagnostic Test: preterm labor; Diagnostic Test: healthy | |
| healthy | 24-36 6/7 weeks of pregnant between the age of 21 and 34 Receives: Diagnostic Test: preterm labor; Diagnostic Test: healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
prostaglandin E2
prostaglandin E2 levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml
Measured: 1 Day
TNF-Alpha
TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml
Measured: 1 day
IL-1beta
IL-1beta levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml
Measured: 1 day
Secondary outcomes (2)
Porphyromonas gingivalis
Presence of Porphyromonas gingivalis will be checked by rPCR method. Score 1: Present Score 2: None
Measured: 1 Day
Tannerella Forsythia
Presence of Tannerella Forsythia will be checked by rPCR method. Score:1 Present. Score 2: None
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start17 Feb 2018
- Primary completion17 Sep 2018 (estimated)
- Study completion15 Dec 2018 (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 Preterm LaborStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Gul Yildiz Telatar, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610841
- Sponsor's protocol ID
- 40465587-26
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available within 6 months of study completion
Publications
Puertas A, Magan-Fernandez A, Blanc V, Revelles L, O'Valle F, Pozo E, Leon R, Mesa F. Association of periodontitis with preterm birth and low birth weight: a comprehensive review. J Matern Fetal Neonatal Med. 2018 Mar;31(5):597-602. doi: 10.1080/14767058.2017.1293023. Epub 2017 Feb 28.
PubMed 28282773
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Possible Relationship Between Preterm Labor and Periodontal Disease With Clinical Periodontal, Biochemical and Microbiological Data
- ClinicalTrials.gov ID
- NCT03610841
- Acronym / sponsor ID
- 40465587-26
- Conditions
- Preterm Labor, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 17 Feb 2018 (actual)
- Primary completion
- 17 Sep 2018 (estimated)
- Study completion
- 15 Dec 2018 (estimated)
- First posted
- 1 Aug 2018 (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.
The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor.
The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.
Detailed description
Preterm infants are born prior to completion of 37 weeks of gestation. Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preterm labor. It is believed that the results will set light to the etiology of preterm labor and will help to develop strategies to prevent the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm labor | – | Diagnostic Test: preterm labor, Diagnostic Test: healthyWorkgroup consists of patients which diagnosed with preterm labor between the age of 21 and 34 |
| healthy | – | Diagnostic Test: preterm labor, Diagnostic Test: healthy24-36 6/7 weeks of pregnant between the age of 21 and 34 |
Who may qualify
- Ages
- 21 to 34 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study is planned to be a case-control study. Workgroup consists of 50 patients which diagnosed with preterm labor between the age of 21 and 34. Control group consists of healthy females 24-36 6/7 weeks of pregnant with no history of preterm labor.
Key inclusion criteria (2 listed)
- pregnant women with preterm labor
- 37. weeks of pregnant women with no history of preterm labor
Key exclusion criteria (14 listed)
- Genitourinary infection
- pregnancy or pre-pregnancy hypertension
- HIV infection
- diabetes mellitus
- multiple pregnancy, preterm labor / low birth weight
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 |
|---|---|---|
| preterm laborAlso: blood sample, urine testliver function tests, kidney function tests and platelets measures the ratio of protein to creatinine | Diagnostic test | healthy, preterm labor |
| healthyAlso: blood sample, urine testliver function tests, kidney function tests and platelets measures the ratio of protein to creatinine | Diagnostic test | healthy, preterm labor |
Primary outcome
prostaglandin E2
Time frame: 1 Day
prostaglandin E2 levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:29-97 pg / ml
TNF-Alpha
Time frame: 1 day
TNF-Alpha levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:42-203pg/ml
IL-1beta
Time frame: 1 day
IL-1beta levels will be evaluated in salivary, serum and placenta samples using ELISA test Normal value:3-227pg/ml
2 secondary outcomes
Porphyromonas gingivalis
Time frame: 1 Day
Tannerella Forsythia
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 28282773Puertas A, Magan-Fernandez A, Blanc V, Revelles L, O'Valle F, Pozo E, Leon R, Mesa F. Association of periodontitis with preterm birth and low birth weight: a comprehensive review. J Matern Fetal Neonatal Med. 2018 Mar;31(5):597-602. doi: 10.1080/14767058.2017.1293023. Epub 2017 Feb 28.
- Association of periodontitis with preterm birth and low birth weightLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be available within 6 months of study completion
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Periodontal Disease, run by Recep Tayyip Erdogan University Training and Research Hospital at 6 sites in 2 countries.
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 2 inclusion and 14 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye), United Kingdom. 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 Gül Yıldız Telatar, Dr. (05365404555, gulyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prostaglandin E2 (time frame: 1 Day). The study lists 3 primary outcomes in all. 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 NCT03610841, 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 1 Aug 2018.