Initial Pregnancy Interview

Evaluating the Quality of Interview Data Collected by Teratology Information

Services About Pregnancy Outcomes, Maternal and Infant Health,

Following Medication Use During Pregnancy and Lactation

09/03/2009

ATTACHMENT D2: INITIAL PREGNANCY Interview

APPROVED

OMb# __0920 -XXXX__________

omb exp. date____/____/_____

SUBJECT ID# ________________

Date of Interview _____/_____/_______

Ask these questions only after informed consent for participation has been obtained and the enrollment interview has been completed.

Note: Read only the wording that appears in regular font when conducting the interview. Wording in italics contains instructions to the interviewer and should not be read.

Section A

Now, I’d like to ask some questions about your pregnancy. I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer.

1. When is your baby due? _____/_____/_______ _____Don’t know or refused

If she is unsure of the exact date, go to Question 3 in this section.

If she refused to answer, go to Question 4 in this section.

2. How did your health care provider decide when your baby is due? Was it by:

(Read all choices except Don’t know or refused; Circle all that apply)

1. The date of your last menstrual period

2. An ultrasound

3. The date of an embryo transfer

4. Another method What method was it? ____________________________________

5. Don’t know or refused

3. When did your last menstrual period begin?

LMP _____/_____/_______ _____Don’t know or refused

4. How many babies are you carrying? For example, is it just one or do you have twins, triplets, or more? ______________________________________ _____Don’t know or refused

Public reporting burden of this collection of information is estimated to average 30 minutes per response, 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 Information Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX).

4. Is this your first pregnancy?

1. Yes

2. No

3. Don’t know or refused

If yes or don’t know/refused, go to Question 14 in this section.

4. How many times have you been pregnant? ___________ _____Don’t know or refused

4. How many live born children have you had? __________ _____Don’t know or refused

4. Did any have a birth defect? This would include physical, internal, or genetic conditions that are not due to a medical complication or illness such as prematurity or infection.

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 10 in this section.

9. What kind of birth defect was it? ________________________________________________

______________________________________________ _____Don’t know or refused

(If she doesn’t know the name of the condition, ask her to describe it and its symptoms)

9. Have you had any miscarriages or stillbirths?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 14 in this section.

9. How many miscarriages or stillbirths have you had? ______ _____Don’t know or refused

9. Did any have a birth defect? This would include physical, internal, or genetic conditions that are not due to a medical complication or illness such as prematurity or infection.

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 14 in this section.

13. What kind of birth defect was it? ________________________________________________

______________________________________________ _____Don’t know or refused

(If she doesn’t know the name of the condition, ask her to describe it and its symptoms)

13. Were you born with a birth defect? This would include physical, internal, or genetic conditions that are not due to a medical complication or illness such as prematurity or infection.

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 16 in this section.

13. What kind of birth defect was it? ________________________________________________

______________________________________________ _____Don’t know or refused

(If she doesn’t know the name of the condition, ask her to describe it and its symptoms)

13. Was your current pregnancy conceived with assisted reproductive technology, such as in vitro fertilization or IVF, intracytoplasmic sperm injection or ICSI, or any other procedure?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Section B.

13. Which procedures were used? (If she is unsure, ask her to describe them)________________

______________________________________________ _____Don’t know or refused

Section B

Next, I’d like to ask about medicines you took at any time during the period from one month before you became pregnant until now. This includes prescription medicines that you got from a doctor or pharmacy; over-the-counter medicines such as Tums or Tylenol; vitamins; herbals; and other dietary supplements. It also includes any medicines you might have taken to help you get pregnant. I’ll be asking about how much you took and how often you took them.

Sometimes it is helpful to have the medicine bottles, a calendar, or other reminder in front of you when answering these questions. Do you want to take a minute to collect these items?

(If yes, wait for her to collect the items, then continue)

Again, I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer.

1. What medicines did you take during the time from one month before you became pregnant until now? List all the medicines you can think of even if you took them for a short time or only occasionally when needed.

(Ask for both trade and generic names of each medicine; If the medicine has a name that is common to multiple preparations, such as Tylenol, ask her for the exact name of the preparation, e.g., Tylenol PM, Tylenol Sinus, Tylenol Arthritis, etc.)

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

2. First/Next, let’s talk about (name of the first/next medicine). What were you taking it for? ________________________ _____Don’t know or refused

If don’t know or refused, go to Question 4 in this section.

3. When did you first have (name of the condition)? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days, weeks, months, or years before ________________________

3. If during pregnancy, weeks or months of gestation _______________________________

4. Mother’s age at onset ______________________________________________________

5. Other response ___________________________________________________________

6. Don’t know or refused

4. When during the time from one month before you became pregnant until now did you first/next take (name of the medicine)? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days or weeks before _____________________________________

3. If during pregnancy, weeks or months of gestation _______________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

5. How many (name of the medicine) pills/teaspoons did you take at a time? ____________________________________ _____Don’t know or refused

6. How many milligrams were in each pill/teaspoon?

______________________________________________ _____Don’t know or refused

7. How often did you take that dose? For example, how many times per day, per week, or per month? (Complete the one that best reflects the answer given)

1. Number of times per day ___________________________________________________

2. Number of times per week __________________________________________________

3. Number of times per month _________________________________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

8. Did the dose of (name of the medicine) or how often you took it change (again) while you were taking it that time?

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused, go to Question 10 in this section.

9. When did the dose of (name of medicine) change? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

   1. Date _____/_____/_______

   2. If before conception, days or weeks before _____________________________________

   3. If during pregnancy, weeks or months of gestation _______________________________

   4. Number of days or weeks after starting the medicine _____________________________

   5. Other response ___________________________________________________________

   6. Don’t know or refused

Go to Question 5 in this section.

10. Are you still taking (name of the medicine) now?

    1. Yes

    2. No

    3. Don’t know or refused

If no, go to Question 12 in this section.

If don’t know/refused, go to Question 14 in this section.

11. And are you still taking (read the dose and frequency from the last response to Questions 6 and 7)?

    1. Yes

    2. No

    3. Don’t know or refused

If yes or don’t know/refused, go to Question 2 in this section for the next medicine on the list. If there are no more medicines on the list, proceed with Question 14 in this section.

If no, ask her to clarify when she started taking her current dose. Then go to Question 2 in this section for the next medicine on the list. If there are no more medicines on the list, proceed with Question 14 in this section.

12. When did you stop taking (name of medicine) that time? For example, how many days or weeks did you take it, or how many weeks pregnant were you when you stopped?

    1. Number of days __________________________________________________________

    2. Number of weeks _________________________________________________________

    3. Number of months ________________________________________________________

    4. Weeks or months of gestation _______________________________________________

    5. Other response ___________________________________________________________

    6. Don’t know or refused

13. Have you taken (name of the medicine) again since then?

    1. Yes

    2. No

    3. Don’t know or refused

If yes, go to Question 4 in this section.

If no or don’t know/refused, go to Question 2 in this section for the next medicine on the list. If there are no more medicines on the list, proceed with Question 14.

14. Did you take any other medicines at any time from one month before you became pregnant until now? This includes things like Tylenol, cold medicine, extra vitamins, or dietary supplements.

    1. Yes

    2. No

    3. Don’t know or refused

If no or don’t know/refused, go to Question 16 in this section.

15. What other medicines did you take during the time from one month before you became pregnant until now? List all the medicines you can think of even if you took them for a short time or only occasionally when needed.

(Ask for both trade and generic names of each medicine; If the medicine has a name that is common to multiple preparations, such as Tylenol, ask her for the exact name of the preparation, e.g., Tylenol PM, Tylenol Sinus, Tylenol Arthritis, etc.)

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

Go to Question 2 in this section for the first/next medicine on the list.

16. If prenatal vitamins have already been mentioned, go to Question 17.

Still thinking about one month before you until became pregnant until now, did you take any prenatal vitamins?

1. Yes

2. No

3. Don’t know or refused

If yes, go to Question 4 in this section.

17. If a folic acid supplement not contained in a multivitamin has already been mentioned, go to Section C.

Still thinking about one month before you until became pregnant until now, did you take a folic acid supplement that was not part of a prenatal or other vitamin that we’ve already talked about?

1. Yes

2. No

3. Don’t know or refused

If yes, go to Question 2 in this section.

Section C

Next, I’d like to ask about any other medical conditions you had during the period from one month before you became pregnant until now that we haven’t already talked about, even if you did not take medicine for them. Examples might be a sore throat or sinus infection, asthma, depression, or a pregnancy-related condition like high blood pressure, gestational diabetes, or too little or too much amniotic fluid.

Again, I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer.

1. Did you have any other medical conditions during this time?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Section D.

2. What conditions did you have? List all that you can think of. _________________________ __________________________________________________________________________

______________________________________________ _____Don’t know or refused

(If she doesn’t know the name of the condition, ask her to describe it and its symptoms)

If refused, go to Section D.

2. First/Next, let’s talk about (name of the first/next condition). When did you first have (name of the condition)? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days, weeks, months, or years before_________________________

3. If during pregnancy, weeks or months of gestation _______________________________

4. Mother’s age at onset ______________________________________________________

5. Other response ___________________________________________________________

6. Don’t know or refused

4. Did you take any medicine for (name of the condition) during the period from one month before you became pregnant until now that we haven’t already talked about?

   1. Yes

   2. No

3. Don’t know or refused

If yes, go to Section B, Question 1.

If no or don’t know/refused and there are other conditions on the list, go to Question 3 in this

section. If there are no more conditions on the list, proceed with Question 5 in this section.

4. Did you have any other medical conditions during the period from one month before you became pregnant until now that we haven’t already talked about?

   1. Yes

   2. No

3. Don’t know or refused

If yes, go to Question 2 in this section.

Section D

Next, I’d like to ask about any injuries or traumas, such as falls or accidents, that you had during the period from one month before you became pregnant until now.

Again, I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer.

1. Did you have any (other) injuries or traumas during this time?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Section E.

2. What was the first/next injury you had? _________________________________________

______________________________________________ _____Don’t know or refused

(If she doesn’t know what the injury is called, ask her to describe it and its symptoms)

2. When did the injury occur? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days or weeks before_____________________________________

3. If during pregnancy, weeks or months of gestation _______________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

4. Did you see a doctor or go to the emergency room to receive treatment for this injury?

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused, go to Question 6 in this section.

4. What treatment did you receive? ________________________________________________

______________________________________________ _____Don’t know or refused

4. Did you take any medicine for this injury that we haven’t already talked about?

   1. Yes

   2. No

   3. Don’t know or refused

If yes, go to Section B, Question 1.

If no or don’t know/refused, go to Question 1 in this section.

Section E

Next I’d like to ask about any prenatal tests or surgery you’ve had since you became pregnant. Again, I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer.

1. Have you had an ultrasound during this pregnancy?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 5 in this section.

2. Did any of the ultrasounds show a problem?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 5 in this section.

3. What was the problem?_____________________________________________________

______________________________________________ _____Don’t know or refused

(If she doesn’t know what it is called, ask her to describe it and its symptoms)

4. When did you have the first ultrasound that showed the problem? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Weeks or months of gestation _______________________________________________

3. Other response ___________________________________________________________

4. Don’t know or refused

5. Have you had an amniocentesis, or amnio, during this pregnancy?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 9 in this section.

5. Did the amnio show a problem?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 9 in this section.

5. What was the problem?_____________________________________________________

______________________________________________ _____Don’t know or refused

5. When did you have the first amnio that showed the problem? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Weeks or months of gestation _______________________________________________

3. Other response ___________________________________________________________

4. Don’t know or refused

5. Have you had chorionic villus sampling, also known as CVS, during this pregnancy?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused go to Question 13 in this section.

5. Did the CVS show a problem?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused , go to Question 13 in this section.

5. What was the problem?_______________________________________________________

______________________________________________ _____Don’t know or refused

5. When did you have the CVS that showed the problem? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Weeks or months of gestation _______________________________________________

3. Other response ___________________________________________________________

4. Don’t know or refused

5. Have you had any other prenatal tests that we haven’t talked about, other than a first trimester screen or other maternal serum screening test?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 18 in this section.

5. What was the first/next other prenatal test that you had? (If she doesn’t know what the test is called, ask her to describe it)___________________________________________________

______________________________________________ _____Don’t know or refused

5. Did it show a problem?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 13 in this section.

5. What was the problem?________________________________________________________

______________________________________________ _____Don’t know or refused

5. When did you have the first test that showed the problem? (Select the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Weeks or months of gestation _______________________________________________

3. Other response ___________________________________________________________

4. Don’t know or refused

Go to Question 13 in this section.

18. Did you have any (other) surgery during the period from one month before you became pregnant until now for which you had general anesthesia? That is, for which you were you put to sleep?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Section F.

19. What kind of surgery did you have?

(If she doesn’t know what the test is called, ask her to describe it)

______________________________________________ _____Don’t know or refused

20. When did you have it?

1. Date _____/_____/_______

2. Weeks or months of gestation _______________________________________________

3. Other response ___________________________________________________________

4. Don’t know or refused

Go to Question 18 in this section.

Section F

Finally, I’d like to ask about some other exposures that you might have had during the period from one month before you became pregnant until now. I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer.

1. Did you smoke a cigarette at any time during the period from one month before you became pregnant until now?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 4 in this section.

2. On average, how many cigarettes did you smoke per day? (1 pack = 20 cigarettes, half a pack = 10)

1. Number of cigarettes_______________________________________________________

2. Number of packs__________________________________________________________

3. Other response ___________________________________________________________

4. Don’t know or refused

3. When was the last time you smoked a cigarette? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days or weeks before _____________________________________

3. Weeks or months of gestation _______________________________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

4. Have others in your home or workplace smoked during the period from one month before you became pregnant until now?

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused, go to Question 6 in this section .

4. How many people in your home or workplace smoked during this time?

_____________________________________________ ______Don’t know or refused

4. Thinking about the period from the time you learned you were pregnant until now, on average how often did you have a drink of alcohol? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of times per day __________________________________________________

2. Number of times per week _________________________________________________

3. Number of times per month ________________________________________________

4. Didn’t drink

5. Other response ___________________________________________________________

6. Don’t know or refused

If she didn’t drink or doesn’t know/refused, go to Question 9 in this section.

4. On average, how many drinks did you have at one time? One drink is equal to one glass of wine like you would have at a restaurant, one bottle or can of beer, or 1 ounce of hard liquor either in a mixed drink or straight up. (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of drinks per day __________________________________________________

2. Number of drinks per week _________________________________________________

3. Number of drinks per month ________________________________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

4. What was the most number of drinks you had on any one occasion during that period? ____________________________________________ ______Don’t know or refused

4. Thinking about the time from one month before you became pregnant until you learned you were pregnant, on average how often did you have a drink? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of times per day __________________________________________________

2. Number of times per week _________________________________________________

3. Number of times per month ________________________________________________

4. Didn’t drink

5. Other response ___________________________________________________________

6. Don’t know or refused

If she didn’t drink or doesn’t know/refused, go to Question 13 in this section.

4. On average, how many drinks did you have at one time? One drink is equal to one glass of wine like you would have at a restaurant, one bottle or can of beer, or 1 ounce of hard liquor either in a mixed drink or straight up. (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of drinks per day __________________________________________________

2. Number of drinks per week ________________________________________________

3. Number of drinks per month ________________________________________________

4. Other response __________________________________________________________

5. Don’t know or refused

11. What was the most number of drinks you had on any one occasion during the time from one month before you became pregnant until you learned you were pregnant? ____________________________________________ ______Don’t know or refused

11. When was the last time you had a drink? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days or weeks before_____________________________________

3. If during pregnancy, weeks or months of gestation ______________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

13. Did you use any (other) recreational drugs during the period from one month before you became pregnant until now?

    1. Yes

    2. No

    3. Don’t know or refused

If no or don’t know/refused, go to End of Interview.

13. What (other) recreational drugs did you use? List all you can think of.

_____________________________________________ ______Don’t know or refused

13. Thinking about the period from the time you learned you were pregnant until now, on average how often did you use <name of the first/next drug>? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of times per day ___________________________________________________

2. Number of times per week __________________________________________________

3. Number of times per month _________________________________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

13. Thinking about the period from one month before you became pregnant until the time you learned you were pregnant, on average how often did you use <name of the drug>? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of times per day ___________________________________________________

2. Number of times per week __________________________________________________

3. Number of times per month _________________________________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

13. When was the last time you used <name of the drug>? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days or weeks before_____________________________________

3. If during pregnancy, weeks or months of gestation ______________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

If there are more drugs on the list, go to Question 15 in this section. If there are no more drugs on the list, proceed with Question 18 in this section.

13. Did you use any (other) recreational drugs during the period from one month before you became pregnant until now?

    1. Yes

    2. No

    3. Don’t know or refused

If yes, go to Question 14 in this section.

If no or don’t know/refused, go to End of Interview.

End of Interview

That is the end of this interview. I truly want to thank you for taking the time to complete it. Your contribution to this study is very important. Before we hang up, do you have any questions for me?____________________________________________________________

___________________________________________________________________________

Your next interview is schedule for when you are about 7 months pregnant. That will be approximately <Calculated date she reaches 7 months based on the Due Date given in Section A, Question 1>.

Go to tracking form.

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