The Impact of Genetic Factors on Pregnancy Outcomes in Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- adverse maternal outcomes of female CP patients
研究概览
简要总结
To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes.
详细描述
The goal of this observational study is to explore the impact of CP susceptibility genes (SPINK1, PRSS1, CTRC, CFTR) on pregnancy outcomes (including both maternal and fetal outcomes) in a large Chinese cohort. Participants will be asked to provide their pregnancy-related data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients with a diagnosis of chronic pancreatitis
- •have known genetic backgrounds and pregnancy history
- •agree to join the study and provide informed consent
排除标准
- •patients without documented pregnancy
- •patients who denied to provide pregnancy-related information, or with incomplete pregnancy characteristics and/or outcomes
- •patients with other autoimmune comorbidities that might influence pregnancy outcomes, such as systemic lupus erythematosus, autoimmune thyroid diseases, etc
结局指标
主要结局
adverse maternal outcomes of female CP patients
时间窗: through study completion, an average of 1 year
* CP-associated caesarean delivery referred to caesarean deliveries which happened due to the attack of CP or comorbidities associated with CP such as GDM and HDP. * CP-associated preterm delivery was defined as preterm deliveries which happened due to the attack of CP or comorbidities associated with CP. * GDM was defined as the onset or first recognition of abnormal glucose tolerance during pregnancy. * Intrahepatic cholestasis of pregnancy was based on characteristic symptoms, as well as elevated serum bile acids, in the absence of other hepatobiliary disease. * HDP included preeclampsia/eclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, and gestational hypertension.
adverse fetal outcomes of female CP patients
时间窗: through study completion, an average of 1 year
* Low birth weight was defined as weight at birth \<2500 g. * CP-associated abortion referred to abortions (i.e., a nonviable intrauterine pregnancy up to 20 weeks' gestation) which happened due to the attack of CP or comorbidities associated with CP. * Congenital anomaly referred to the inborn errors of development. * Stillbirth was defined as the delivery of a fetus ≥20 weeks of gestation with no signs of life.
次要结局
未报告次要终点