ZIRP - Pregnant Woman Follow-Up Questionnaire

Att. C 4

Form Approved

OMB No. 0920-XXXX

Exp. Date XX/XX/20XX

Site code	Participant code	Pregnant Woman
I I	I I I I	I 0 I

Today’s date: _____/______/________

MM DD YYYY

ZIKV RNA Persistence (ZIRP): Pregnant-Woman Follow-up Questionnaire

1. Study visit #:____________

2. Study visit location:

₁ Obstetric clinic

₂ Laboratory

₃ Pediatrician’s office

3. Date of last study visit (mm/dd/yyyy): ____________

4. Have the last two study related blood draws come out negative for Zika virus infection by RT-PCR?

₁ Yes ₀ No

TO BE COMPLETED BY PATIENT

PART I: General Health

We will now ask you questions about your general health and any changes to it since your last study visit.

5. Have you visited the emergency room since your last visit? ₁ Yes ₀ No

1. If yes, reason of visit_____________________ Name of facility__________________

6. Have you been hospitalized since your last visit? ₁ Yes ₀ No

2. If yes, reason of hospitalization_______________ Name of facility_________________

7. Have you had an outpatient visit not requiring an ER visit or hospitalization? ₁ Yes ₀ No

3. If yes, reason of visit_____________________ Name of facility__________________

8. Have you had blood taken since your last visit? ₁ Yes ₀ No

1. If yes,

   1. Reason of blood collection____________

9. Have you had urine taken since your last visit? ₁ Yes ₀ No

1. If yes,

   1. Reason of urine collection____________

10. Have you had a blood transfusion since your last visit? ₁ Yes ₀ No

    1. If yes,

       1. Reason for transfusion ____________

       2. Date (mm/dd/yyyy) ____________

11. Has there been any change to your overall health since the last visit? ₁ Yes ₀ No

    1. If yes, specify____________

12. Have you delivered your baby since your last visit? ₁ Yes ₀ No

12a. If yes,

12a₁. Date of delivery: (mm/dd/yyyy): ____________

12a₂. Was it a live-birth: ₁ Yes ₀ No

13. If you have not delivered, where do you plan to deliver (provide the name of facility)?

____________________________________

TO BE COMPLETED BY STUDY STAFF

PART I: Microbiological Testing

14. Was a blood specimen taken? ₁ Yes ₀ No

14a. If no, why?

₀ The last two study related blood draws came out negative for Zika virus infection

₁ Other, specify ____________________________________

14.b. If yes,

14.b.1. Date of specimen collection (mm/dd/yyyy): ____________

14.b.2 Time of specimen collection (hh:mm): ____________

14.b.3. Date specimen was sent to laboratory (mm/dd/yyyy): ____________

14.b.4. Type of test:

₀ RT-PCR

_1. IgM

_2. RT-PCR & IgM

₃ Other

15. Was a urine sample taken? ₁ Yes ₀ No

15a. If no, why?

₀ The last two study related urine samples came out negative for Zika virus infection

₁ Other, specify ____________________________________

15.b. If yes,

15.b.1. Date of specimen collection (mm/dd/yyyy): ____________

15.b.2 Time of specimen collection (hh:mm): ____________

15.b.3. Date specimen was sent to laboratory (mm/dd/yyyy): ____________

15.b.4. Type of test:

₀ RT-PCR

_1. IgM

_2. RT-PCR & IgM

_3. Other

PART II: Study Termination

16. Was the subject terminated from the study? ₁ Yes ₀ No

16a_1. If yes, date of study termination (mm/dd/yyyy): ____________

16a_2. If yes, reason:

₀ Last two sample collections tested negative for Zika confirmed by rRT-PCR

₁ End of study period

₂ Admitted to hospital for adverse outcomes

₃ Loss to follow-up

₄ No longer wants to participate in study

₅ Terminated by study staff

₅ Other, specify ____________________________________

Public reporting burden of this collection of information is estimated to average 8 minutes, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74,  Atlanta, Georgia 30333; ATTN:  PRA (0920-1189).