A Comparative Evaluation to Evaluate the Correlation Between Cervical Cerclage or Vaginal Progesterone and Maternal Vaginal Microbiome Distribution During Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- vaginal microbiome distribution between the arms
研究概览
简要总结
A comparative evaluation to evaluate the correlation between cervical cerclage or vaginal progesterone and maternal vaginal microbiome distribution during pregnancy
详细描述
Cervical insufficiency is primarily a clinical diagnosis, characterized by painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of otherwise normal pregnancies.
Adverse perinatal events associated with cervical insufficiency include prolapse of the fetal membranes into the vagina, intra-amniotic infection, preterm premature rupture of membranes, preterm labor and fetal loss.
Congenital and acquired cervical abnormalities increase the risk of cervical insufficiency; Acquired risk factors are more common and include cervical trauma during delivery, rapid mechanical cervical dilation before a gynecologic procedure or treatment of cervical intraepithelial neoplasia (1). Congenital abnormalities include genetic disorders affecting collagen, uterine anomalies and in the past - in utero diethylstilbestrol (DES) exposure (2, 3).
The diagnosis of cervical insufficiency is based on either
- History of painless cervical dilatation with preterm (midtrimester) delivery
- History of prior second-trimester pregnancy losses or preterm births and cervical length ≤25 mm on transvaginal ultrasonography examination or advanced cervical changes on physical examination before 24 weeks of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •G- roup 1 - Pregnant women with a singleton gestation and cervical cerclage at 12-14 weeks of gestation due to obstetrical history characteristic of cervical insufficiency G- roup 2 - Pregnant women with a singleton gestation at 12-14 weeks of gestation without a history of cervical insufficiency
- •Group 3 - Pregnant women treated with progesterone due to previous preterm labor without cerclage
排除标准
- •A- cute cervical insufficiency P- roven or suspected chorioamnionitis P- remature rupture of membranes F- etal structural abnormality G- estation beyond 15 weeks A- ntibiotic usage in the past month P- robiotic use in the past month R- eported autoimmune disease or immunosuppressive disorder
研究组 & 干预措施
cervicall cerclage
to test vaginal microbiome distribution in women with cervical cerclage due to cervical incompetence in weeks: 12 14 18 26 32
干预措施: vaginal swab -microbiome test and blood test for cytokines (Diagnostic Test)
vaginal progesterone
to test vaginal microbiome distribution in women treated with vaginal progesterone due to cervical shortening in weeks: 12 14 18 26 32
干预措施: vaginal swab -microbiome test and blood test for cytokines (Diagnostic Test)
contol
to test vaginal microbiome during pregnancies without cerclage or progesterone
结局指标
主要结局
vaginal microbiome distribution between the arms
时间窗: 5 years
次要结局
未报告次要终点