Corona Virus Disease 2019 Cohort Study

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development

ClinicalTrials.gov ID

NCT06927622

Acronym / sponsor ID

LL202303018

Conditions

COVID-19 Pneumonia, COVID-19 Pandemic, COVID-19

Keywords

pregnant woman, birth cohort, infant, nervous system development

Study type

Observational

Recruitment status

Recruiting

Enrolment

1,000 participants (estimated)

Lead sponsor

Shandong UniversityUniversity, hospital or other

Collaborators

Qilu Hospital of Shandong University, Jinan Maternity and Child Health Care Hospital, Shandong Provincial Maternity and Child Health Care Hospital, The Second Hospital of Shandong University, Qianfoshan Hospital

Study start

1 Apr 2023 (actual)

Primary completion

1 Dec 2025 (estimated)

Study completion

1 Jun 2026 (estimated)

First posted

15 Apr 2025 (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.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

1 Year

Who may qualify

Ages

18 years and older

Sex

Female only

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Study population

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST).

   Time frame: From 6 months of birth to completion of the GDS measurement, the assessment is up to 6 months

   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.

2. Pregnancy complications or comorbidities

   Time frame: Starting prenatal examination until discharge，the evaluation take up to 10 months

   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.

3. Obtain neonatal outcomes.

   Time frame: The evaluation period from birth to discharge is up to 1 week

   Obtain neonatal outcomes from neonatal records, including macrosomia, neonatal asphyxia, fetal distress, low birth weight infants, and deformed infants.

4. Comprehensive results of COVID-19 infection during pregnancy

   Time frame: Baseline data were obtained when participants were enrolled in the study and assessed for up to 1 years

   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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
• Individual participant dataSharing planned: Yes. 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.

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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.

5 sites in 1 country: see every site and its status.