Reporting template for the use of the gaia (Global Alignment of Immunisation Safety Assessment in pregnancy) outputs



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Reporting template for the use of the GAIA (Global Alignment of Immunisation Safety Assessment in pregnancy) outputs

In 2015-2016, the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) partners, with support from the Bill and Melinda Gates Foundation, developed


  • standardized case definitions of neonatal and obstetric key terms for the assessment of safety of immunization in pregnancy as per the Brighton Collaboration format,

  • guidance documents for the conduct of clinical trials of vaccines in pregnancy

The GAIA outputs are increasingly being utilized in current and forthcoming clinical and observational studies for Immunization in Pregnancy and for studies in the field of Maternal and Child Health. A reporting template for the use of GAIA outputs is given below.

As key stakeholders in the field, if you become aware of the use of GAIA outputs, please list current/future projects of Immunization in Pregnancy or Maternal and Child Health Studies, further details of the study, which GAIA documents are being used / planned to be used in each project, and any other information if available and email this word document to info@gaia-consortium.net and ct@gaia-consortium.net.



Your help in generating high quality safety data on Immunization in Pregnancy and the field of Maternal and Child Health is invaluable.


Type of Study (please enter the no. in the column below)

  1. Clinical or Observational Study for Immunization in Pregnancy

  2. Pharmacovigilance for Immunization in Pregnancy

  3. Maternal or Child Health study

  4. Others (please specify)

Title/Details of Study as available

  • Phase

  • Vaccine name

  • Study site/

Country


Principle Investigators/ Point person, Contact Details

GAIA Documents used in this project (please enter the numbers from the list below)

Advantages of utilizing GAIA outputs

Challenges encountered/ expected to be encountered with the utilization of GAIA outputs, Suggestions for Improvement















































































































GAIA Documents:

  1. Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

  2. Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy.

  3. Maternal death

  4. Non-reassuring Fetal Status

  5. Postpartum Haemorrhage

  6. Pre-mature Labour

  7. Hypertensive disorders of pregnancy/ Pre-Eclampsia/ Eclampsia

  8. Abortion

  9. Antenatal Bleeding

  10. Fetal Growth Restriction

  11. Gestational Diabetes

  12. Dysfunctional Labor

  13. Preterm birth (including Gestational Age Assessment Algorithm)

  14. Stillbirth

  15. Congenital Anomalies

  16. Neonatal Death

  17. Neonatal Infection

  18. Low Birth Weight

  19. Small for Gestational Age

  20. Neonatal Encephalopathy

  21. Respiratory Distress

  22. Failure to Thrive

  23. Microcephaly

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