The Role and Mechanism of Vitamin D in Recurrent Spontaneous Abortion Based on Maternal Fetal Interface Immune Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,421
- 试验地点
- 1
- 主要终点
- Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes2
研究概览
简要总结
The observational study is to compare vitamin D deficiency and related indicators among different spontaneous abortions in describe female reproductive health.The main question aim to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin D.
Participants, who visit the RSA specialty clinic, will provide medical history information, regularly exam based on the condition, following up on pregnancy status.Participants will be asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect after treatment.
详细描述
Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes tested voluntarily, plasma VD content and the level of anticardiolipin antibody.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of patients without spontaneous abortion;
- •Clinical diagnosis of patients with a spontaneous abortion;
- •Clinical diagnosis of patients with recurrent pontaneous abortions;
排除标准
- •Patients with chromosomal abnormalities in RSA couples, such as balanced translocation;
- •Patients who take VD preparations or related VD supplements within 3 months before treatment;
- •Patients with a combination of certain malignant tumors and severe mental illness.
结局指标
主要结局
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes2
时间窗: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as biochemical pregnancy which refers to the phenomenon where the sperm and egg combine but fail to return to the uterus for implantation, leading to miscarriage along with menstruation.
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes3
时间窗: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as loss of fetal heart rate which refers to the cessation of fetal heartbeat during pregnancy leading to miscarriage.
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes1
时间窗: average of 1 year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as empty sac which refers to the absence of a fetal sac or embryo bud (the amniotic sac is empty).
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes4
时间窗: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as spontaneous miscarriage in large months (greater than 12 weeks but less than 28 weeks) which refers to the cause of fetal death in the uterus, vaginal bleeding or flowing and abdominal pain leading to miscarriage.
Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes5
时间窗: average of half of a year
Through outpatient follow-up, follow-up and inpatient information, pregnancy outcomes are classified according to Williams obstetrics, such as failure of fetal heart rate which the inability of the fetus to detect heartbeat leading to miscarriage.
次要结局
- The difference of age in different number of spontaneous abortions(one day)
- The change of plasma VD content in spontaneous abortions before and after supplying vitamin D(average of 1 year)
- The difference of BMI in different number of spontaneous abortion(one day)
- The difference of uterine artery resistance parameter S/D in different number of spontaneous abortions(dynamic monitoring, average of half of a year)
- The abnormality of some embryonic chromosomes tested voluntarily in spontaneous abortions(a month)
- The change of the level of plasma anticardiolipin antibody in spontaneous abortions before and after supplying vitamin D(average of 1 year)
研究者
Jianmei Xia
Deputy Chief Physician
First People's Hospital of Hangzhou