Attachment E - Interview Schedule

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

09/03/09

Pilot Project for Major Adverse Effects of

Medication Use During Pregnancy and Lactation

8/15/08

ATTACHMENT E: Schedule of interviews

Participants will be enrolled in one of three follow-up groups, depending on their medication exposure:

Pregnancy Exposure Group – Women who contact the TIS about taking a medication during pregnancy, but do not breastfeed.

Interview #1 - Enrollment and Initial Pregnancy Questionnaires: Within 14 days (ideally within 7 days) of contacting one of the TIS.

Interview #2 - Follow-Up Pregnancy Questionnaire: Within 14 days (ideally within 7 days) of reaching 32 weeks (7 months) of gestation. If the mother has already delivered, the Initial Infant Interview will be conducted instead.

Interview #3 - Initial Infant Questionnaire: Within 14 days (ideally within 7 days) of the date the infant is one month of age.

Interview #4 - Follow-Up Infant Questionnaire: Within 14 days (ideally within 7 days) of the date the infant is three months old.

Lactation Exposure Group – Women who contact the TIS about taking a medication while breastfeeding.

Interview #1 - Enrollment and Initial Breastfeeding Questionnaires: Within 14 days (ideally 7 days) of contacting one of the TIS.

Interview #2 - Follow-Up Breastfeeding Questionnaire: Within 14 days (ideally within 7 days) of the date equivalent to one month after the Initial Breastfeeding Interview.

Interview #3 - Second Follow-Up Breastfeeding Questionnaire: For breastfeeding mothers who are taking a chronic medication or who frequently take a periodic medication, a second follow-up breastfeeding interview will be conducted within 14 days (ideally within 7 days) of the date equivalent to three months after the Initial Breastfeeding Interview.

Pregnancy and Lactation Exposure Group – Women who contact the TIS about taking a medication during pregnancy and who breastfeed after delivery.

Interview #1 - Enrollment and Initial Pregnancy Questionnaires: Within 14 days (ideally within 7 days) of contacting one of the TIS.

Interview #2 - Follow-Up Pregnancy Questionnaire: Within 14 days (ideally within 7 days) of reaching 32 weeks (7 months) of gestation. If the mother has already delivered, the Initial Infant Interview will be conducted instead.

Interview #3 - Initial Infant Questionnaire, and Initial Breastfeeding Questionnaire if the woman has taken a medication while breastfeeding: Within 14 days (ideally within 7 days) of the date the infant is one month of age.

Interview #4 - Follow-up Infant Questionnaire, and Follow-up Breastfeeding Questionnaire if the woman has taken a medication while breastfeeding: Within 14 days (ideally within 7 days) of the date the infant is three months old.

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