Periodontitis, preeclampsia
Conditions
Interventions
Disease-Specific Cohort (Cohort Study):None
Probiotic Group (RCT):Oral probiotic administration on the basis of standard periodontitis treatment
Placebo Group (RCT):Oral administration of placebo on the basis of standard periodontitis treatment
Sponsors
Shenzhen Maternity & Child Healthcare Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Cohort study: 1. Aged 18 years and above, with singleton pregnancy 2. Gestational age between 11 weeks 0 days and 13 weeks 6 days, with normal fetal status 3. Registered in the hospital and able to receive stable follow-up 4. Have been enrolled in the cohort of "China Maternal Preeclampsia Risk Prediction Research Project" 5. Have signed the informed consent form; 2.RCT: 1.Aged 18 years and above, with singleton pregnancy 2.Gestational age between 11 weeks 0 days and 13 weeks 6 days, with normal fetal status 3.Meet the criteria for high-risk early-onset preeclampsia: using the FMF screening model; high-risk is defined as those with a screening index > 1/100 4.Meet the diagnostic criteria for periodontitis 5.Voluntarily agree to participate in this study and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Cohort study: 1. Regular use of aspirin or long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) before enrollment; use of antibiotics within the past 3 months; receipt of periodontal treatment within 12 months. 2. Suffering from severe mental disorders and unable to express willingness. 3. Those who underwent induced labor due to social factors, fetal malformations, or chromosomal abnormalities (excluding those with abortions or induced labor related to gestational hypertension disorders). 4. Individuals with obvious other abnormal physical signs, laboratory test results, or clinical diseases, who are judged by the research team to be unsuitable for participation in the study. 2.RCT: 1.Presence of any factors that may cause adverse maternal-fetal outcomes identified at the time of enrollment screening, such as systemic diseases, smoking, alcohol abuse, placenta previa, placental abruption, etc. 2.Those with fetal abnormalities identified at the time of enrollment screening who are unable to undergo normal delivery 3.Having known chronic diseases that affect pregnancy outcomes, such as pre-pregnancy diabetes mellitus, autoimmune diseases, etc. 4.Having a medication history of drugs that interfere with the pregnancy process 5.Having any adverse reactions to probiotics 6.Active peptic ulcer or gastrointestinal bleeding 7.Learning difficulties or severe mental illnesses 8.Severe medical conditions 9.Those who have participated in other clinical trials within one month prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| low birth weight infants (Cohort Study);neonatal death (Cohort Study);preterm birth (Cohort Study);fetal growth restriction (Cohort Study);stillbirth (Cohort Study);Incidence rate of early-onset preeclampsia (RCT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Other adverse maternal-fetal outcomes;Incidence rate of severe preeclampsia (RCT);Periodontitis indicators; | — |
Countries
China
Contacts
Public ContactPing Wen
Shenzhen Maternity & Child Healthcare Hospital
Outcome results
None listed