The Influence of Prenatal Factors on Maternal Hemorrhage

NCT04517617 | Unknown

• 1 other identifier: XJTU1AF2018LSK-245
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Keywords

pregnancy; prenatal factors; environment; genetics; hemoglobin; blood loss

Outcome Measures

Primary Outcomes (1)

• The Influence of Prenatal Factors Including Environment on Maternal Hemorrhage.

  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

Study Arms (1)

The level of maternal air pollution exposure during pregnancy

The groups will be decided according to the level of maternal exposure to air pollution during pregnancy. Participants will be divided into experimental group (high level of maternal air pollution exposure) and control group (low level of maternal air pollution exposure) or other groups according to research and actual demand.

Other: The level of air pollution

Interventions

The level of air pollution OTHER

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.

The level of maternal air pollution exposure during pregnancy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• The First Affiliated Hospital of the Fourth Military Medical University: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be taken before and after childbirth to detect serum level of hemoglobin.

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenfang Yang, Ph.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenfang Yang, Ph.D

CONTACT

+862985323223; wenfang.yang@xjtu.edu.cn

Ruiqi Wang

CONTACT

0086-18101161205; q619354975@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: June 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 29, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)