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The Influence of Prenatal Factors on Maternal Hemorrhage (TIOPFOMH)

The Influence of Prenatal Factors Including Environment on Maternal Hemorrhage

This research evaluates the effects of prenatal factors on adverse pregnancy outcomes, the general demographic information, the level of maternal exposure to air pollution, the environmental condition, pregnancy-related information, the occurrence of adverse pregnancy outcomes, and serum indicators of pregnant women during pregnancy are collected. Finally, the research explores that whether prenatal factors including environment can mediate the occurrence of maternal hemorrhage.

研究概览

地位

招聘中

条件

详细说明

The degree of hemoglobin changes before and after delivery can be used as an index, to accurately estimate postpartum hemorrhage in clinical practice. Postpartum hemorrhage is the leading cause of maternal death in the world, accounting for 30% of maternal deaths. Studies have shown that most deaths caused by postpartum hemorrhage are avoidable. Domestic and foreign literature reports that the incidence of postpartum hemorrhage is 5%~10%, however, the amount of blood loss clinically estimated is often lower than the actual amount, the actual incidence of postpartum hemorrhage is higher. A large number of studies have confirmed that maternal exposure to air pollution during pregnancy such as particulate matter (PM), nitrogen dioxide (NO2), sulfur dioxide (SO2), ozone (O3), carbon monoxide (CO) can increase the risk of adverse pregnancy outcomes, including miscarriage, gestational diabetes mellitus(GDM), hypertensive disorder complicating pregnancy, preterm birth and low birth weight(LBW). So, a prospective cohort study is conducted to explore the influence of prenatal factors and environment on maternal hemorrhage.

Research content: This research is a prospective cohort study from June 2020 to December 2022, 500 pregnant women will be recruited from the First Affiliated Hospital of Xi'an Jiaotong University and First Affiliated Hospital of the Fourth Military Medical University. A health management birth cohort will be established. ①To construct a spatial and temporal series about maternal hemorrhage influenced by maternal exposure to air pollution during pregnancy; ②To explore the effects of prenatal factors and environment on maternal hemorrhage.

Research meaning:① Practical significance: To explore the factors that affect maternal hemorrhage, and to reduce the occurrence of postpartum hemorrhage, which contributes to reducing the healthy risks and medical economic burdens caused by the healthy problems of mothers and children. ② To define the critical period of the developing of maternal hemorrhage in spatial and temporal series, and to calculate the cutoff value of air pollution on maternal hemorrhage, propose short-term control target of air pollution related to maternal and child health, construct the first-level prevention strategy for adverse pregnancy outcomes.

Research steps: ① Complete the recruiting of subjects, which meet the inclusion and exclusion criteria sign an informed consent before the carrying out of research; ② Follow up: Questionnaires will be conducted to acquire the information including sociodemographic characteristics, menstrual history and childbearing history, residence during pregnancy, lifestyle and diet habits, the information of illness and medication, history of past illness, etc. Then the maternal exposure level of air pollutants in every trimester will be calculated, based on air pollution detection station, from Shaanxi Meteorological and Environment Bureau according to residence information of participants; ③ Serum indicators: fasting venous blood samples will be taken before and after childbirth to detect serum level of hemoglobin, all the blood samples will be taken and tested in the laboratory of the First Affiliated Hospital of Xi'an Jiaotong University and First Affiliated Hospital of the Fourth Military Medical University; ④ Monitoring of postpartum hemorrhage: closely monitor the volume of blood loss. During the whole study period, the subjects could withdraw the cohort at any time.

Prenatal hemoglobin level: blood hemoglobin level within one week before delivery; Postpartum hemoglobin level: blood hemoglobin level 1 day after delivery; The difference of hemoglobin before and after delivery: prenatal hemoglobin level minus postpartum hemoglobin level (if he patient received red blood cell transfusion during this period, this value is the degree of hemoglobin change after calibration); The 24 h postpartum hemorrhage is calculated as 400 ml for every 10g/L drop in hemoglobin; Birth weight: the weight of newborn within the first hour.

Statistical method: ①Univariate analysis: The maternal exposure levels of air pollution during pregnancy will be treated as independent variables, postpartum hemorrhage will be treated as dependent variables, univariate logistic regression will be used to analyze the relationship between them; ②Multivariate analysis: postpartum hemorrhage will be taken as dependent variables, maternal exposure levels, sociodemographic characteristics, nutritional status, dietary status, and other factors are included as independent variables, the multivariate logistic regression analysis will be used to data analysis. In the multivariate regression the odds ration value and 95% confidence intervention of air pollution to affect adverse pregnancy outcomes will be calculated adjusted for sociodemographic characteristics, nutrition, dietary conditions and other factors; ③Spatial and temporal series analysis will be adapted to define the critical period of the developing of postpartum hemorrhage under maternal exposure to air pollution, and calculate the cut-off value of air pollution about postpartum hemorrhage.

Research planning: ①Complete research design, follow-up questionnaires, and pre-experiments before July 2020; ②Complete enrollment of subjects, collect pregnancy-related information, follow-up of the study subjects, detecting of serum indicators, monitor the occurrence of postpartum hemorrhage before July 2022; ③Complete data export and analysis about basic information and data analysis; ④Clarify the relationship between maternal air pollution exposure during pregnancy and postpartum hemorrhage, explore the potential mechanism in the occurrence of postpartum hemorrhage influenced by prenatal factors and environment.

研究类型

观察性的

注册 (预期的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Shaanxi
      • Xi'an、Shaanxi、中国、710061
        • 招聘中
        • First Affiliated Hospital of Xi'an JiaoTong University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

概率样本

研究人群

The study participants are healthy pregnant women from the First Affiliated Hospital of Xi'an Jiaotong University and First Affiliated Hospital of the Fourth Military Medical University, who meet the inclusion and exclusion criteria, and sign the informed consent before the implementation of this research.

描述

Inclusion Criteria:

  • The Pregnant women gave birth in the First Affiliated Hospital of Xi'an Jiaotong University and First Affiliated Hospital of the Fourth Military Medical University;
  • This pregnancy is natural conception, the last menstrual period is definite and the menstrual cycle is basically regular;
  • The pregnant women volunteer to participate in this study and sign the informed consent.

Exclusion Criteria:

  • The pregnant women have placental abruption;
  • The pregnant women have placenta previa;
  • The pregnant women have placental implantation;
  • The pregnant women have placental abruption;
  • The pregnant women with incomplete clinical records.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
孕妇孕期空气污染暴露水平
小组将根据孕期母亲暴露于空气污染的程度来决定。 参与者将根据研究和实际需求分为实验组(孕产妇空气污染暴露水平高)和对照组(孕产妇空气污染暴露水平低)或其他组。
The intervention measure is the level of air pollution, it is a non-human interventional measure based on the weighted average of various air pollutants monitored by air pollution monitoring stations during different period of pregnancy.he perinatal period.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The Influence of Prenatal Factors Including Environment on Maternal Hemorrhage.
大体时间:Prenatal hemoglobin level: blood hemoglobin level within one week before delivery; Postpartum hemoglobin level: blood hemoglobin level 1 day after delivery
The 24 h postpartum hemorrhage is calculated as 400 ml for every 10g/L drop in hemoglobin; The difference of hemoglobin before and after delivery: prenatal hemoglobin level minus postpartum hemoglobin level (if he patient received red blood cell transfusion during this period, this value is the degree of hemoglobin change after calibration);
Prenatal hemoglobin level: blood hemoglobin level within one week before delivery; Postpartum hemoglobin level: blood hemoglobin level 1 day after delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Wenfang Yang, Ph.D、First Affiliated Hospital Xi'an Jiaotong University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月1日

初级完成 (预期的)

2023年6月30日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2020年8月14日

首先提交符合 QC 标准的

2020年8月14日

首次发布 (实际的)

2020年8月18日

研究记录更新

最后更新发布 (实际的)

2022年4月29日

上次提交的符合 QC 标准的更新

2022年4月27日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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