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| Name | Class |
|---|---|
| Qilu Hospital of Shandong University | OTHER |
| Jinan Maternity and Child Health Care Hospital | UNKNOWN |
| Shandong Provincial Maternity and Child Health Care Hospital | UNKNOWN |
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The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.
The main questions it aims to answer are:
Researchers will compare Corona Virus Disease 2019 infection group and uninfected group during pregnancy to see if Corona Virus Disease 2019 infection has adverse effects on pregnant women and their offspring.
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| Measure | Description | Time Frame |
|---|---|---|
| Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST). | GDS mainly diagnoses four abilities: motor ability, object ability, speech ability, and human ability,. Thus, the development quotient of four aspects can be obtained. If the development quotient is below 65-75, it indicates serious backwardness. The DST assessment includes five functional areas: gross motor, fine motor, language, adaptability, and social behavior, to obtain developmental quotient, which is used to measure the developmental behavior of children and evaluate their level of development. A score above 130 indicates excellent performance, and a score below 70 indicates intellectual development disorder. | From 6 months of birth to completion of the GDS measurement, the assessment is up to 6 months |
| Pregnancy complications or comorbidities | Obtain relevant information from medical records. Pregnancy complications refer to non pregnancy related diseases that occur before or during pregnancy, while pregnancy complications refer to any diseases that coexist with pregnancy. | Starting prenatal examination until discharge，the evaluation take up to 10 months |
| Obtain neonatal outcomes. | Obtain neonatal outcomes from neonatal records, including macrosomia, neonatal asphyxia, fetal distress, low birth weight infants, and deformed infants. | The evaluation period from birth to discharge is up to 1 week |
| Comprehensive results of COVID-19 infection during pregnancy | Through questionnaires, medical records and test sheets, The investigators can get whether the pregnant women have been infected with COVID-19 during pregnancy, the time of infection, pregnancy weeks, symptoms, etc. | Baseline data were obtained when participants were enrolled in the study and assessed for up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery method | Natural delivery, vaginal surgery, or curettage. | The evaluation period from admission to delivery to discharge is up to 1 week |
| Estimation of bleeding volume | Total amount of bleeding during or 24 hours postpartum. |
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Inclusion Criteria:
Exclusion Criteria:
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The population of this study is pregnant women who undergo regular prenatal examinations in hospitals, establish a prenatal care manual, plan hospital delivery, have no comorbid tumor diseases, are mentally normal, and are aged ≥ 18 years old.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Chen, Doctorate | Contact | 18615656606 | 86 | 202216407@mail.sdu.edu.cn |
| Yinuo Song | Contact | 17861203953 | 86 | 363197039@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Fanzhen Hong, Doctorate | The Second Hospital of Shandong University | Study Director |
| Xia Luo, Doctorate | Qilu Hospital of Shandong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
The investigators will only allow users to use the data and supporting files based on a clear data sharing agreement, which enforces (a) their commitment to use the data only for research purposes and will not identify any individual study participants; (b) Promise to use appropriate technology to protect all research data; (c) Prohibit the redistribution of data to third parties and appropriately confirm data resources, as well as (d) commit to destroying and/or returning data after analysis is completed. Co investigators can access data collected as part of their purpose. The investigators involved in this project can only access the data through the chief investigator. The investigators will regularly monitor data to maintain security, safety, and productivity.
The investigators will be provided within 1 Year after the release of the main research findings
Access is only provided after submitting research proposals and obtaining approval from an independent review team, as well as after the data sharing agreement is in place.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| The Second Hospital of Shandong University |
| OTHER |
| Qianfoshan Hospital | OTHER |
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| The evaluation period from admission to delivery to discharge is up to 1 week |
| Yueqin Xu, Doctorate |
| Qianfoshan Hospital |
| Study Director |
| Qiuhong Yang, Doctorate | Jinan Maternity and Child Health Care Hospital | Study Director |
| Jie Chen, Doctorate | Shandong University | Study Chair |
| Yinuo Song, Master | Shandong University | Principal Investigator |
| Jinan Maternity and Child Health Care Hospital | Recruiting | Jinan | China |
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| Qianfoshan Hospital | Recruiting | Jinan | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | China |
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| Shandong Provincial Maternity and Child Health Care Hospital | Recruiting | Jinan | China |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |