Protocols for PIN1 and PIN2
Protocols for PIN1 and PIN2
Subject Identification
Recruitment and Specimen Collection
Nutritional Assessments
Life Events Questionnaire
The Main Telephone Questionnaire
Follow-up Telephone Questionnaire During Pregnancy
After Delivery
Postpartum Specimen Collection and Hair Questionnaire
Follow-up Telephone Questionnaire After Delivery
Medical Chart Review
Specimen Assays
Contextual Data
Subject Identification
Potential subjects were 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 were excluded. Some demographic and pregnancy-related data was entered from the chart into a computerized tracking file.
Recruitment and Specimen Collection
Women were recruited at their prenatal visit occurring after gestational week 24 and before the end of week 29. Project staff explained the study to the woman and ask her to participate. If she agreeed, the following activities occurred:
- the informed consent form was signed
- some basic demographic data were collected
- a phone interview was scheduled to occur within the next two weeks
- additional specimens were collected by clinicians during the routine physical exam:
- urine: for cotinine and illicit drugs assessment
- blood: for micronutrient assessment
- genital tract swabs: for bacterial vaginosis, pH, group B strep, and fibronectin assessment
- an endovaginal ultrasound was performed to assess the cervix
- specimen processing and storage was done by project staff
Nutritional Assessments
At the clinic recruitment, women were 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 were collected for assessment of preconceptional nutritional status.
A validation study of the Food Frequency Questionnaire was done employing repeated measures with a 24-hour recall collected with the NDS system.
The Life Events Questionnaire
At the clinic recruitment, the woman was given a Life Events Questionnaire to assess several psychosocial domains, including:
- life events
- social support
- coping
- depression
- perceived discrimination
- perceived safety of the woman’s neighborhood
Upon completion, the women mailed the questionnaire to the PIN Study office.
The Main Telephone Questionnaire
Women were called within two weeks of their clinic recruitment and interviewed about the following:
- current pregnancy information: symptoms of infection, nausea, bleeding
- vitamin and mineral supplement use
- knowledge about HIV and AIDS
- attitudes about the pregnancy
- employment during pregnancy
- reproductive and medical history
- sexual behavior during pregnancy
- health behaviors: use of tobacco, alcohol, recreational drugs
- physical activity
- father’s characteristics
Follow-up Telephone Questionnaire During Pregnancy
Among 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:
- new pregnancy information
- health behavior changes
- sexual behavior changes
- employment changes
- physical activity changes
After Delivery
Delivery logs at study hospitals were examined daily to determine delivery information on all study participants.
Postpartum Specimen Collection and Hair Questionnaire
All women who were part of the predetermined subcohort and women who delivered preterm were asked to give an additional urine specimen and a hair specimen after delivery. A study staff member visited the woman in the hospital to obtain these specimens and administered a Hair Questionnaire.
Follow-up Telephone Questionnaire After Delivery
All women delivering preterm and the women in the subcohort were interviewed after their pregnancy ended to obtain information about changes in their behavior since the last phone interview. Topics include:
- new pregnancy information
- health behavior changes
- sexual behavior changes
- employment changes
- physical activity changes
Medical Chart Review
Medical charts for the preterm cases and the controls were examined to determine:
- pregnancy outcome of the preterm cases (both preterm PROM and labor) and the subcohort
- additional pregnancy information from prenatal care visits, triage visits, and admissions to the hospital, including delivery admission
- medical history
- pregnancy history
- prenatal laboratory test results that were not in the automated system
Computerized data sources for laboratory results were obtained for the cohort.
Specimen Assays
Various biological specimens were assessed for exposures of interest.
Assessments for the full cohort include:
- fibronectin
- pH
- bacterial vaginosis via gram stain
- group B strep
Assessments for the preterm cases and controls:
- folate measures in serum or plasma, red blood cells, and whole blood (in a subset)
- serum transferrin receptor
- serum ferritin
- urinary cotinine
- urinary drug panel for cocaine and other drugs
- hair assessment for cocaine and other drugs
- homocysteine (in a subset)
- defensins
- plasma vitamin C (in a subset)
- some genetic factors
- vitamin D
Contextual Data
Up to four addresses were obtained from each woman during the Main Telephone Questionnaire and these addresses were geocoded with longitude and latitude and Census block group identifiers allowing linkage to contextual data sources.