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Clinical Trials/CTRI/2021/06/034432
CTRI/2021/06/034432
Completed
未知

Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparas (ASPIRIN): Neurodevelopmental Follow-up Trial

Thrasher Research Fund0 sites4,820 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Thrasher Research Fund
Enrollment
4820
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
March 30, 2019
Last Updated
2 years ago
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. For a prior study sponsored by the Global Network for Women’s and Children’s Health Research, the child’s parents gave permission to re\-contact.
  • 2\. The child’s parent/guardian is willing and able to provide consent for the child and willing also to participate in the child’s assessment (e.g., by providing answers to ASQ\-3 and the Family Resources and Context questionnaire).
  • 3\. The child will be between 33 and 39 months of age at time of assessment.
  • 4\. The child does not have a significant congenital anomaly (e.g., blindness or deafness) that would affect development or preclude them from completing the BSID\-III. This will be left at the discretion of the Senior Foreign Investigator (SFI) with the ability to consult with the Working Committee as needed.
  • 5\. Other significant medical conditions that would preclude the child from completing a BSID III are absent. This will be left to the discretion of the Senior Foreign Investigator who will have the ability to consult with the Working Committee as needed.

Exclusion Criteria

  • Children not meeting the inclusion criteria will be excluded. Likewise, children may be excluded at the discretion of the site investigator out of concern for the child’s wellbeing (e.g. distress with testing).

Outcomes

Primary Outcomes

Not specified

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