Periodontal Pathogens and Inflammatory Biomarkers in Missed Abortion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorNecmettin Erbakan University
About this trial
This observational case-control study will investigate whether periodontal infection and inflammation are associated with missed abortion in pregnancies without detected major fetal chromosomal abnormalities.
A total of 160 pregnant women aged 18 to 40 years and at 20 weeks of gestation or earlier are planned to be enrolled. The study will include 80 women diagnosed with missed abortion and 80 women with an ongoing uncomplicated pregnancy matched according to age and gestational week.
Participants will undergo a clinical periodontal examination, and unstimulated saliva samples will be collected. Saliva will be analyzed for selected periodontal bacteria, including Porphyromonas gingivalis, Fusobacterium nucleatum, and Tannerella forsythia, as well as inflammatory biomarkers.
Serum obtained from blood samples already collected as part of routine obstetric care will be used to measure inflammatory biomarkers, including IL-1β, IL-6, TNF-α, CRP, MMP-8, and prostaglandin E2. No additional blood sample will be collected solely for this study. Routine complete blood count results will also be used to calculate systemic inflammatory indices.
For participants with missed abortion, study samples and periodontal assessments will be obtained after the diagnosis has been confirmed and before uterine evacuation or medical treatment. Routine fetal genetic test results will be reviewed, and cases with detected chromosomal abnormalities included in the clinical genetic assessment will be excluded from the main analysis.
The study aims to determine whether periodontal pathogen burden, periodontal disease, and local and systemic inflammatory responses differ between women with missed abortion and women with ongoing uncomplicated pregnancies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female participants aged 18-40 years Pregnancy at 20 weeks of gestation or earlier For the case group: diagnosis of missed abortion For the control group: ongoing uncomplicated pregnancy Provision of written informed consent
Disqualifiers
Detected fetal chromosomal or genetic abnormality Current smoking Alcohol use Diabetes mellitus Hypertension Autoimmune disease Antibiotic use within the previous 3 months Induced abortion Multiple pregnancy
Trial population
The study population will consist of pregnant women aged 18-40 years at 20 weeks of gestation or earlier who are followed at the Department of Obstetrics and Gynecology, Necmettin Erbakan University. The case group will include women diagnosed with missed abortion who meet the eligibility criteria and have no detected fetal chromosomal abnormalities based on the available routine genetic evaluation. The control group will include women with an ongoing uncomplicated pregnancy and will be matched to cases according to age (±2 years) and gestational age (±1 week).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 2 trial groupsGroup A: Missed Abortion Group
Group B: Healthy Pregnancy Control Group
Trial outcomes
Primary outcomes
1
Salivary Porphyromonas gingivalis Burden
Porphyromonas gingivalis burden in unstimulated whole saliva will be quantitatively assessed using real-time polymerase chain reaction (qPCR). Bacterial burden will be reported using the quantitative output of the assay, such as bacterial copy number or bacterial load normalized to total bacterial load.
Time frame
Baseline2
Salivary Fusobacterium nucleatum Burden
Fusobacterium nucleatum burden in unstimulated whole saliva will be quantitatively assessed using real-time polymerase chain reaction (qPCR). Bacterial burden will be reported using the quantitative output of the assay, such as bacterial copy number or bacterial load normalized to total bacterial load.
Time frame
Baseline3
Salivary Tannerella forsythia Burden
Tannerella forsythia burden in unstimulated whole saliva will be quantitatively assessed using real-time polymerase chain reaction (qPCR). Bacterial burden will be reported using the quantitative output of the assay, such as bacterial copy number or bacterial load normalized to total bacterial load.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov