The document summarizes a study on Zika virus (ZIKV) infection in pregnant women. ZIKV can be transmitted through mosquito bites, sexual contact, or from mother to fetus. While most infections are asymptomatic, ZIKV infection during pregnancy can cause microcephaly and other fetal brain defects in the developing fetus. The objectives of the study are to measure the incidence of ZIKV infection in pregnant women and identify risk factors for adverse maternal and fetal outcomes. The study was approved by ethics committees and uses informed consent. It found high rates of live births but also stillbirths and miscarriages. Many women withdrew due to advice against participation or not wanting blood draws. Next steps include establishing a community advisory

1. Background to Zika Virus (ZIKV)

2. Transmission and Symptoms of Zika
 Zika can be transmitted through:
• Mosquito bites – primary mechanism
• From a pregnant woman to her fetus
• Sexual contact
• Blood transfusion
 The most common symptoms are
Fever, Rash, Joint pain & Conjunctivitis
 80% of infections asymptomatic
 Severe disease requiring
hospitalization is uncommon

3. How does Zika affect pregnant women?
• Zika virus can pass from a
pregnant woman to her
fetus during pregnancy or
around the time of birth
• Zika infection in
pregnancy is a cause of
microcephaly and other
severe fetal brain defects
• Linked to other problems, such
as miscarriage, stillbirth, and
birth defects
• Full range of other potential
health problems that Zika virus
infection during pregnancy
may cause are under
investigation
• No reports of infants getting
Zika through breastfeeding.

4. Main Study Objectives
i. Measure the incidence of ZIKV infection in pregnant
women
ii. Identify risk factors for adverse outcomes, in the
fetuses/newborns and women in the cohort

5. Ethical considerations and Approvals
• Protocol approved by Ethics and Research Committees
• Informed Consent from all participants
• Subject confidentiality measures undertaken
• All study staff have undertaken GCP training

6. Deliveries and Delivery Outcomes
Total CG PR BM
All deliveries 242
• Live newborn 223 39 104 80
• Still birth 15 5 6 4
• Miscarriage 4 2 1 1
• 75% of the deliveries occurred in the study
hospitals
• Mean Newborn Birthweight 3050gms

7. Study Withdrawals and Exit
• 44 withdrawals in total
• Reasons for withdrawal
– Spouse advised against participation --27%
– Participant Wish – 23%
– Do Not Want Multiple Blood Draws -- 25%
– Moved Town --14%
– Other (Please Specify) --11%
• 12 formally exited after completing study procedures

8. Laboratory Slides

9. Slide 1

10. Slide 2

11. Challenges/Emerging issues
• Enrolment during first trimester low
• Need to improve tracking of deliveries in the study site

12. Next steps
• Launch the Community Advisory Board
• Continue recruitment and follow up in all sites
• Explore other research questions within the current
cohort procedures

13. Additional Slides