Maternal Oral Microbiota and Immune Signatures Associated With Spontaneous Labor Onset: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Differences in oral microbiota composition between labor-onset and non-labor groups
研究概览
简要总结
This study investigates how the oral microbiome (the community of microorganisms living in the mouth) and immune system change around the time of spontaneous labor onset in healthy pregnant women.
We will enroll 55 healthy pregnant women at full term (37 weeks or later). Participants will be divided into two groups: women who have begun labor and women who have not yet begun labor. We will collect saliva samples to analyze the oral bacteria using genetic sequencing, and collect blood and placental samples to measure immune factors (proteins that help regulate the body's immune response).
By comparing the two groups, we aim to identify specific bacteria and immune factors that are associated with the start of labor. This research will help us better understand the biological processes that trigger childbirth and may contribute to improved prediction and management of labor onset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 18 to 35 years
- •Pre-pregnancy body mass index (BMI) of 18.5 to 23.9 kg/m²
- •Naturally conceived singleton pregnancy
- •No obstetric complications
- •Written informed consent obtained prior to enrollment
排除标准
- •Polyhydramnios, oligohydramnios, gestational hypertension, gestational diabetes, or other pregnancy-related disorders
- •History of cervical surgery or previous preterm birth
- •Antibiotic or probiotic use during the current pregnancy
- •Current oral diseases or dental/oral procedures within the previous six months
- •Uterine malformations
- •Chronic conditions such as immune system disorders, hypertension, diabetes, gastrointestinal diseases, or hyperthyroidism
- •Smoking, alcohol consumption, or other adverse lifestyle habits
研究组 & 干预措施
Labor-Onset Group (LO)
干预措施: None (Observational Study) (Other)
Non-Labor Group (NLO)
干预措施: None (Observational Study) (Other)
结局指标
主要结局
Differences in oral microbiota composition between labor-onset and non-labor groups
时间窗: At sample collection (39-40 gestational weeks for NLO group; first stage of labor for LO group)
Relative abundance of oral microbiota (%), assessed by 16S rRNA gene sequencing of the V3-V4 hypervariable regions (primers 341F/806R), with paired-end 2 x 250 bp sequencing on the Illumina NovaSeq 6000 platform, in saliva samples from 55 participants (LO, n = 28; NLO, n = 27)
Differences in plasma immune factor levels between labor-onset and non-labor groups
时间窗: At sample collection (39-40 gestational weeks for NLO group; first stage of labor for LO group)
Concentration of immune markers, including TLR-4, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-18, IL-22, TNF-α, and IL-1β (pg/mL), in plasma, assessed by enzyme-linked immunosorbent assay (ELISA) using commercially available kits (Shanghai Fusheng Industrial Co., Ltd.), in 55 participants (LO, n = 28; NLO, n = 27)
Differences in placental immune factor levels between labor-onset and non-labor groups
时间窗: At sample collection (placental tissues collected within 15 minutes postpartum)
Concentration of immune markers, including TLR-4, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-18, IL-22, TNF-α, and IL-1β (pg/mL), in placental tissue homogenates, assessed by enzyme-linked immunosorbent assay (ELISA) using commercially available kits (Shanghai Fusheng Industrial Co., Ltd.), in 50 participants (LO, n = 25; NLO, n = 25)
次要结局
未报告次要终点
研究者
Zhe Li
Principal Investigator
Third Affiliated Hospital, Sun Yat-Sen University