ZIRP - Pregnant Woman Enrollment Questionnaire

Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP)

Att C2 - Pregnant Woman Enrollment Questionnaire

Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire

OMB: 0920-1217

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Att. C 2

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 Enrollment Questionnaire


Shape1

TO BE COMPLETED BY PATIENT


Part I:Demographics


Thank you for agreeing to participate in this study. If you at any point have any questions about the questions in this form please ask the study staff. First, we will start by asking you some questions about yourself.


  1. What was your pre-pregnancy weight/height?


Weight ________ 1 Pounds 2 Kilograms 77 Don’t know 88 Refuse

Height ________ 1 Inches 2 Centimeters 77 Don’t know 88 Refuse


  1. What is your birthdate? __ __/__ __ /__ __ __ __ 77 Don’t know 88 Refuse

M M D D Y Y Y Y



3. What is the highest level of education that you have completed?


1 Less than primary 2 Primary 3 Secondary 4 Technical 5 University or +

77 Don’t know 88 Refuse


4. What is your marital status?


1 Single 2 Married or domestic partnership 3 Widowed 4 Divorced 5Separated 6 Other 77 Don’t know 88 Refuse


5. What type of medical insurance do you have?


1 Reforma (Medicaid) 2 Private (through work, spouse or parents) 3 Self-paid 4 None 77 Don’t know 88 Refuse


6. What type of home do you live in?


1 House/apartment (owned) 2 House/apartment (rented) 3 Public housing 4 Lives with friends or relatives 5 Homeless 88 Refuse





Part II:Medical History

We will now ask you questions about your past medical history.


7. Please indicate if you have had of any of the following conditions by marking “yes” or “no”. If you mark yes in any of the conditions please fill out the third column to the right of each individual condition. If you are unsure about the diagnosis date please provide your best guess or mark “not sure”.




Yes

No

Don’t know

If yes……,

Asthma




Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Blood transfusion




Date of Last Transfusion:

(mm/dd/yyyy): _______ Not Sure

Cancer




Type: _________________________

Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Cardiovascular (Heart) Disease




Pulmonary Embolism

Rheumatic Heart Disease

Congenital Heart Disease

Peripheral Arterial Disease

Aortic Aneurysm and Dissection

Deep venous thrombosis

Pulmonary Embolism

Stroke

Other

Don’t Know


Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Diabetes




Type:

Type I

Type II

Gestational diabetes

Not Sure


Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Hepatitis




Type:

A

B

C

D

E

Don’t Know

Diagnosis Date (mm/dd/yyyy): _______ Not Sure

High Blood Pressure




Diagnosis Date(mm/dd/yyyy): _______ Not Sure

HIV




Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Kidney Disease




Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Liver Disease




Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Mosquito-borne illnesses




2 Dengue

Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Diagnosis Date (mm/dd/yyyy): _______ Not Sure

3 Chikungunya

Diagnosis Date (mm/dd/yyyy): _______ Not Sure

Sexually Transmitted Disease




Type:

Chlamydia

Gonorrhea

Genital Herpes

Genital Warts

Syphillis

Crabs

Trichomoniasis

Other

Don’t Know


Diagnosis Date (mm/dd/yyyy): _______ Not Sure



Part III: Pregnancy


We will now ask you questions about your pregnancy history.


8. Do you know the first day of your last menstrual cycle? 1 Yes 0 No


8.1 If Yes, what was the date?, __ __/__ __ /__ __ __ __

M M D D Y Y Y Y


9. Do you know your due date? 1 Yes 0 No


9.1 If Yes, what is your due date?, __ __/__ __ /__ __ __ __

M M D D Y Y Y Y



10. How many babies are you expecting?: 1 Single 2 Twins 3 Triplets 4 Other


11. How many times were you pregnant before this pregnancy?


_________ times 1 This is my first pregnancy 77 Don’t know 88 Refuse


12. During this pregnancy, have you been told you have gestational diabetes?

1 Yes 0 No 77 Don’t know 88 Refuse



Part IV: Sexual History


We will now ask you questions about your sexual history.



13. How many men have you had unprotected sex with during your pregnancy?


1 1 2 2 3 3 or more 4 None 77 Don’t know 88 Refuse


14. Since the start of your pregnancy, how often have you had vaginal sex with a man? Choose the best answer.


1 Once a day or more

2 Two or more times a week

3 Once a month

4 Less than once a month

5 Never

77 Don’t know

88 Refuse


15. Since the start of your pregnancy, when you had sex, how often has your partner used a condom?


1 Always 2 Very often 3 Sometimes 4 Rarely 5 Never 6 Not applicable 77 Don’t know 88 Refuse




Part V: Medications


We will now ask you questions about any prescription medications, over the counter medications, and supplements you are currently taking


16. Are you taking any prescription medications? 1 Yes 0 No 77 Don’t know 88 Refuse

16.1 If Yes, Name_______________________________ Dose ________________________________

Name_______________________________ Dose ________________________________


Name_______________________________ Dose ________________________________

Name_______________________________ Dose ________________________________


Name_______________________________ Dose ________________________________


17. Are you taking any over the counter medications? 1 Yes 0 No 77 Don’t know 88 Refuse

17.1 If Yes, Name_______________________________ Dose ________________________________

Name_______________________________ Dose ________________________________


Name_______________________________ Dose ________________________________

Name_______________________________ Dose ________________________________


Name_______________________________ Dose ________________________________


18. Are you taking any vitamins/minerals/supplements? 1 Yes 0 No 77 Don’t know 88 Refuse

18.1 If Yes, Name_______________________________ Dose ________________________________

Name_______________________________ Dose ________________________________


Name_______________________________ Dose ________________________________

Name_______________________________ Dose ________________________________


Name_______________________________ Dose ________________________________





























Shape2

TO BE COMPLETED THROUGH MEDICAL RECORD ABSTRACTION

Part I: Demographics


  1. What is the patient’s current weight/height?


Weight ________ 1 Pounds 2 Kilograms 77 Don’t know 88 Refused

Height ________ 1 Inches 2 Centimeters 77 Don’t know 88 Refused



  1. Has the patient been vaccinated for…?


Yellow fever

1 Yes 0 No 77 Don’t know


If yes, Date of most recent vaccination (mm/dd/yyyy): _______

Dengue

1 Yes 0 No 77 Don’t know


If yes, Date of most recent vaccination (mm/dd/yyyy): _______

Influenza

1 Yes 0 No 77 Don’t know


If yes, Date of most recent vaccination (mm/dd/yyyy): _______


Part II: Obstetric History


Complete if patient reported having previous pregnacies.


3. Did the patient have any of the following in their previous pregnancies…


Live Birth

1 Yes 0 No 77 Don’t know


If yes, # of pregnancies: __________, year __________

year __________

year __________

year __________

year __________


Miscarriage (loss before 20th week)

1 Yes 0 No 77 Don’t know


If yes, # of pregnancies: __________, year __________

year __________

year __________

year __________

year __________


Stillbirth (loss at or after the 20th week)

1 Yes 0 No 77 Don’t know


If yes, # of pregnancies: __________, year __________

year __________

year __________

year __________

year __________


Abortion

1 Yes 0 No 77 Don’t know


If yes, # of pregnancies: __________, year __________

year __________

year __________

year __________

year __________


Ectopic or molar pregnancy

1 Yes 0 No 77 Don’t know


If yes, # of pregnancies: __________, year __________

year __________

year __________

year __________

year __________



4. During any of the patient's previous pregnancies, did they …?


Have gestational diabetes (diabetes diagnosed in pregnancy)

1 Yes 0 No 77 Don’t know

Have a premature birth (delivery before 37 weeks)

1 Yes 0 No 77 Don’t know

Have a Cesarean section

1 Yes 0 No 77 Don’t know

Have a baby with a major birth defect

1 Yes 0 No 77 Don’t know









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