Women's Hospital School of Medicine Zhejiang University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Number of participants with different pregnant outcome
研究概览
简要总结
Recurrent pregnancy loss (RPL) is a refractory disease with diverse etiologies, complex pathogenesis and limited therapeutic options. Current tests and treatments lack uniform specifications. This study is a prospective clinical cohort study which intends to screen out meaningful examination items and reliable and effective treatment. The study content includes (1) tracking the re-pregnancy information of patients with initial inevitable abortion, comparing the clinical data and examination test results between patients with single abortion and RPL, and (2) comprehensively and systematically screening the patients with initial inevitable abortion, taking those without obvious abnormalities and those with a re-pregnancy into the control group and taking those with a re-pregnancy after abnormal findings were treated into the study group, recording the pregnancy and perinatal conditions of the two groups, comparing the pregnancy outcomes of the two groups, and analyzing the risk factors for RPL. The results of this study will establish a model of maternal and newborn risk assessment for first trimester medication use and provide strong evidence-based evidence to clarify the diagnosis and treatment processes of RPL.
详细描述
Objective: (1) to establish a prediction model of pregnancy outcome and apply it to clinical practice; (2) to standardize the diagnosis and treatment of RPL.
This study is an observational study. The investigators only collect the medical data of patients without any intervention in the diagnosis and treatment plan. The data collection is in the charge of specially-assigned members of the investigators. The investigators set a security password for the database. The data is collected from outpatient medical record system, inpatient medical record system and questionnaire. One investigator is responsible for inputting the data into the database, and another investigator is responsible for checking the Corrigendum.
- Before enrollment, the investigators would record the medical history of the couple in detail, including age, menstruation, marriage and reproductive history, family history, and the details of previous abortion.
- The following examinations should be completed before pregnancy: in addition to the routine pre-pregnancy examination items, the examination items related to recurrent spontaneous abortion were added, including uterine artery resistance ultrasound, couple's chromosome, reproductive hormone, OGTT test and some immune related indexes.
- According to the examination results, the experts of recurrent spontaneous abortion team would evaluate the patients and divided them into:
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Control group:those who needn't clinical intervention before or after pregnancy , pregnancy was prepared under the clinical and health care guidance provided by experts, and intrauterine pregnancy was confirmed within the study period.
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Observation group: those who need clinical intervention before or after pregnancy, the experts shall formulate a personalized treatment plan according to the international guidelines. Investigators wouldn't interfere with the expert diagnosis and treatment process. And they should be confirmed intrauterine pregnancy within the study period.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) patients who were treated in the outpatient department of Zhejiang University Women's Hospital from January 1, 2018 to December 31, 2020;
- •(2) With history of once spontaneous abortion;
- •(3) Having fertility requirements but not yet pregnant;
- •(4) Those who are willing to give birth again during the study period.
排除标准
- •(1) Previous history of multiple spontaneous abortion, inevitable abortion or missed abortion;
- •(2) Re pregnancy after abortion, now in pregnancy or delivered;
- •(3) Patients who are participating in other clinical studies or those who refuse to participate in the study;
- •(4) The researchers consider that she is not suitable to participate in this study for other reasons.
结局指标
主要结局
Number of participants with different pregnant outcome
时间窗: From date of enrollment until the date of termination of pregnancy, assessed up to 24 months.
Number of participants with abortion, preterm birth, stillbirth, induced labor, flat birth or cesarean section
次要结局
未报告次要终点