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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.

調査の概要

状態

募集

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Shaanxi
      • Xi'an、Shaanxi、中国、710061
        • 募集
        • First Affiliated Hospital of Xi'an JiaoTong University
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年~45年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:コホート
  • 時間の展望:見込みのある

コホートと介入

グループ/コホート
介入・治療
妊娠中の母親の大気汚染暴露レベル
グループは、妊娠中の母親の大気汚染への曝露レベルに応じて決定されます。 参加者は、研究と実際の需要に応じて、実験グループ(母親の大気汚染への暴露レベルが高い)と対照群(母親の大気汚染への暴露レベルが低い)またはその他のグループに分けられます。
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
The Influence of Prenatal Factors Including Environment on Maternal Hemorrhage.
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Wenfang Yang, Ph.D、First Affiliated Hospital Xi'an Jiaotong University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年6月1日

一次修了 (予想される)

2023年6月30日

研究の完了 (予想される)

2023年6月30日

試験登録日

最初に提出

2020年8月14日

QC基準を満たした最初の提出物

2020年8月14日

最初の投稿 (実際)

2020年8月18日

学習記録の更新

投稿された最後の更新 (実際)

2022年4月29日

QC基準を満たした最後の更新が送信されました

2022年4月27日

最終確認日

2021年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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