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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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

500

Kontakter och platser

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Studiekontakt

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Studieorter

    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • Rekrytering
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 45 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Nivån på mödrars exponering för luftföroreningar under graviditeten
Grupperna kommer att bestämmas utifrån graden av mödrars exponering för luftföroreningar under graviditeten. Deltagarna kommer att delas in i experimentgrupp (hög nivå av mödrar luftföroreningar exponering) och kontrollgrupp (låg nivå av mödrar luftföroreningar exponering) eller andra grupper enligt forskning och faktisk efterfrågan.
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Influence of Prenatal Factors Including Environment on Maternal Hemorrhage.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Wenfang Yang, Ph.D, First Affiliated Hospital Xi'an Jiaotong University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2020

Primärt slutförande (Förväntat)

30 juni 2023

Avslutad studie (Förväntat)

30 juni 2023

Studieregistreringsdatum

Först inskickad

14 augusti 2020

Först inskickad som uppfyllde QC-kriterierna

14 augusti 2020

Första postat (Faktisk)

18 augusti 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2022

Senast verifierad

1 augusti 2021

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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