COVID-19NCT06186947
Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health
An observational study of COVID-19, run by Shandong University at 1 site in China.
Trial summary
This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- COVID-19
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with reproductive needs are recruited for study.
Who may be able to join
- Women aged between 18-50 years old.
- Patients with signed informed consent.
- Patients with complete COVID-19 infection information.
Who cannot join
- Patients with abnormal karyotype
- Recipients of oocyte donation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Women, Children and Reproductive Health
Jinan, Shandong, 250012
Han Zhao, +0086 531 82950556, hanzh80@sdu.edu.cn
About this study
Official title: Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health: A Large Cohort Study
This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.
Read the detailed description
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:
- Undergo a questionnaire to gather details on COVID-19 infection history.
- Provide data about reproductive history.
- Be invited for physical examination, laboratory tests and ultrasound scans.
- Undergo a long-term follow up for pregnancy outcome and offspring health.
- Conditions
- COVID-19
- Being tested
- No intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Participants are not subjected to any specific intervention.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | Patients infected by SARS CoV2 before reproductive events. Receives: Other: No intervention | |
| Control group | Patients who were not infected by SARS CoV2 before reproductive events. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy is defined as the ultrasound confirmation of at least one gestational sac.
Measured: 7 weeks after the day of embryo transfer
Ongoing pregnancy rate
Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation.
Measured: 12 weeks after the day of embryo transfer
Secondary outcomes (3)
Live birth rate
Live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
Measured: 10 months after the day of embryo transfer
Pregnancy loss rate
Pregnancy loss is defined as pregnancy that eventuates in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
Measured: 10 months after the day of embryo transfer
Congenital malformation rate
The number of the malformation neonates/the number of the neonates alive ×100%.
Measured: 12 months after the day of embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Sep 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University of Traditional Chinese Medicine, The Second Hospital of Shandong University, The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital, Yantai City Yantai Mountain Hospital, Jining First People's Hospital, Weifang People's Hospital, Affiliated Hospital of Jining Medical University, Linyi People's Hospital, Dezhou People's Hospital, The Affiliated Hospital of Binzhou Medical College, Liaocheng People's Hospital, The Second People's Hospital of Liaocheng, Linyi Maternal and Child Healthcare Hospital, Heze Hospital of Traditional Chinese Medicine, Weihai maternal and child health care hospital, Weifang Maternal and Child Health Hospital, Taian City Central Hospital, Zibo Maternal and Child Health Hospital, Qingdao Women and Children's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Qilu Hospital of Shandong University, The Affiliated Hospital of Weifang Medical College, Shandong Provincial Maternal and Child Health Care Hospital, Ren Ji Hospital of Shanghai Jiao Tong University
- Responsible party
- Principal investigator, Chen Zi-Jiang, Shandong University
- Investigators
- Zi-Jiang Chen, Study chair, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186947
- Sponsor's protocol ID
- COVREP
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health: A Large Cohort Study
- ClinicalTrials.gov ID
- NCT06186947
- Acronym / sponsor ID
- COVREP
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong University of Traditional Chinese Medicine, The Second Hospital of Shandong University, The Affiliated Hospital of Qingdao University, Yantai Yuhuangding Hospital, Yantai City Yantai Mountain Hospital, Jining First People's Hospital, Weifang People's Hospital, Affiliated Hospital of Jining Medical University, Linyi People's Hospital, Dezhou People's Hospital, The Affiliated Hospital of Binzhou Medical College, Liaocheng People's Hospital, The Second People's Hospital of Liaocheng, Linyi Maternal and Child Healthcare Hospital, Heze Hospital of Traditional Chinese Medicine, Weihai maternal and child health care hospital, Weifang Maternal and Child Health Hospital, Taian City Central Hospital, Zibo Maternal and Child Health Hospital, Qingdao Women and Children's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Qilu Hospital of Shandong University, The Affiliated Hospital of Weifang Medical College, Shandong Provincial Maternal and Child Health Care Hospital, Ren Ji Hospital of Shanghai Jiao Tong University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.
Detailed description
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:
- Undergo a questionnaire to gather details on COVID-19 infection history.
- Provide data about reproductive history.
- Be invited for physical examination, laboratory tests and ultrasound scans.
- Undergo a long-term follow up for pregnancy outcome and offspring health.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | – | Other: No interventionPatients infected by SARS CoV2 before reproductive events. |
| Control group | – | Other: No interventionPatients who were not infected by SARS CoV2 before reproductive events. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with reproductive needs are recruited for study.
Key inclusion criteria (3 listed)
- Women aged between 18-50 years old.
- Patients with signed informed consent.
- Patients with complete COVID-19 infection information.
Key exclusion criteria (2 listed)
- Patients with abnormal karyotype
- Recipients of oocyte donation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionParticipants are not subjected to any specific intervention. | Other | COVID-19 group, Control group |
Primary outcome
Clinical pregnancy rate
Time frame: 7 weeks after the day of embryo transfer
Clinical pregnancy is defined as the ultrasound confirmation of at least one gestational sac.
Ongoing pregnancy rate
Time frame: 12 weeks after the day of embryo transfer
Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation.
3 secondary outcomes
Live birth rate
Time frame: 10 months after the day of embryo transfer
Pregnancy loss rate
Time frame: 10 months after the day of embryo transfer
Congenital malformation rate
Time frame: 12 months after the day of embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zi-Jiang Chen study chair
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zi-Jiang Chen (+0086 531 85187856, chenzijiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 7 weeks after the day of embryo transfer). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.