Protocols for PIN1 & PIN2Subject IdentificationPotential subjects are identified through a review, by study staff, of all medical charts of new prenatal patients. Women less than age 16 at 24 weeks gestation, non-English speaking women, women not planning to continue care or delivery at the study site, or women with multiple gestations are excluded. Some demographic and pregnancy-related data is entered from the chart into a computerized tracking file. Recruitment and Specimen CollectionWomen are recruited by study staff at their prenatal visit occurring after gestational week 24 and by the end of week 29. Project staff explain the study to the woman and ask her to participate. If she agrees, the following activities occur:
Nutritional AssessmentsAt the clinic recruitment, women are given a modified version of the Block Food Frequency Questionnaire to assess diet during the second trimester, preconceptional Vitamin C intake, and vitamin and mineral supplement use prior to conception and during pregnancy. Pregravid weight and height are collected for assessment of preconceptional nutritional status. A validation study of the Food Frequency Questionnaire is underway employing repeated measures with a 24-hour recall collected with the NDS system. The Life Events QuestionnaireAt the clinic recruitment, the woman is also given a Life Events Questionnaire to assess several psychosocial domains, including:
Upon completion, the women mail the questionnaire to the PIN Study office. The Main Telephone QuestionnaireWomen are called within two weeks of their clinic recruitment and interviewed about the following:
Follow-up Telephone Questionnaire During PregnancyAmong the first 2500 women recruited, approximately 25% were randomly selected to be controls and were re-contacted during pregnancy between 29 and 36 weeks gestation to obtain information about changes in their behavior since the last phone interview. This component was dropped in February 1999. Topics included were:
After DeliveryDelivery logs at study hospitals are examined daily to determine delivery information on all study participants. Postpartum Specimen Collection and Hair Questionnaire:All women who are part of the control group and women who deliver preterm are asked to give an additional urine specimen and a hair specimen after delivery. A study staff member visits the woman in the hospital to obtain these specimens and administer a short Hair Questionnaire. Follow-up Telephone Questionnaire After Delivery:All women delivering preterm and the women in the control group are interviewed after their pregnancy ends to obtain information about changes in their behavior since the last phone interview. Topics include:
Medical Chart ReviewMedical charts for the preterm cases and the controls are examined to determine:
Computerized data sources for laboratory results are obtained for the cohort. Specimen AssaysVarious biological specimens are assessed for exposures of interest. Assessments for the full cohort include:
Assessments for the preterm cases and controls:
Contextual DataUp to four addresses are obtained from each woman during the Main Telephone Questionnaire and these addresses are geocoded with longitude and latitude and Census block group identifiers allowing linkage to contextual data sources.
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