Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health

NCT ID: NCT06186947

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-12-31

Brief Summary

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This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.

Detailed Description

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The influence of SARS-CoV-2 infection on reproductive outcomes has been uncertain. The goal of this observational study is to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health for patients with childbearing needs.

Participants will:

1. Undergo a questionnaire to gather details on COVID-19 infection history.
2. Provide data about reproductive history.
3. Be invited for physical examination, laboratory tests and ultrasound scans.
4. Undergo a long-term follow up for pregnancy outcome and offspring health.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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COVID-19 group

Patients infected by SARS CoV2 before reproductive events.

No intervention

Intervention Type OTHER

Participants are not subjected to any specific intervention.

Control group

Patients who were not infected by SARS CoV2 before reproductive events.

No intervention

Intervention Type OTHER

Participants are not subjected to any specific intervention.

Interventions

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No intervention

Participants are not subjected to any specific intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Women aged between 18-50 years old.
2. Patients with signed informed consent.
3. Patients with complete COVID-19 infection information.

Exclusion Criteria

1. Patients with abnormal karyotype
2. Recipients of oocyte donation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Yantai Yuhuangding Hospital Affiliated to Qingdao University

UNKNOWN

Sponsor Role collaborator

Yantai City Yantai Mountain Hospital

UNKNOWN

Sponsor Role collaborator

the First People's Hospital of Jining

UNKNOWN

Sponsor Role collaborator

Weifang People's Hospital

OTHER

Sponsor Role collaborator

Jining Medical University

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Dezhou People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Binzhou Medical College

UNKNOWN

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

The Second People's Hospital of Liaocheng

UNKNOWN

Sponsor Role collaborator

Linyi Maternal and Child Healthcare Hospital

UNKNOWN

Sponsor Role collaborator

Heze Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Weihai maternal and child health care hospital

UNKNOWN

Sponsor Role collaborator

Weifang Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Tai'an City Central Hospital

UNKNOWN

Sponsor Role collaborator

Zibo Maternal and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Qingdao Women and Children's Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Weifang Medical College

UNKNOWN

Sponsor Role collaborator

Maternal and Child Health Care Hospital of Shandong Province

UNKNOWN

Sponsor Role collaborator

Ren Ji Hospital of Shanghai Jiao Tong University

UNKNOWN

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Chen Zi-Jiang

Academician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zi-Jiang Chen

Role: STUDY_CHAIR

Shandong University

Locations

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Institute of Women, Children and Reproductive Health

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zi-Jiang Chen

Role: CONTACT

+0086 531 85187856

Facility Contacts

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Han Zhao

Role: primary

+0086 531 82950556

Other Identifiers

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COVREP

Identifier Type: -

Identifier Source: org_study_id

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