Table 5

Schedule B (Data collection after detection of menstruation delay or pregnancy)
Task Timing Procedure Forms
Verification of pregnancy and measuring folate levels (if pregnant). - Whenever delay in menstruation of 14 days or more or pregnancy are identified at either at bi-monthly follow-up or contact with subject between follow-ups - Request that subject completes a pregnancy test within a week after detection of menstruation delay if pregnancy is not confirmed (For clinic based model, pregnancy can be tested for at study clinic). - FA19 to document pregnancy test result
- Schedule an in-person follow-up within a week after confirming pregnancy (if subject is not in clinic when first confirmed). An in-person follow-up in this case is only required if pregnancy occurs before the end of first year post initiation of supplementation and blood sampling is required for folate measurement. - FA16 to document folate level
Obtain blood samples for a folate testing (if applicable). - FA06 (if pregnancy is confirmed)
- If pregnancy is confirmed, calculate gestational age and advise subject as when to stop taking the study pills
- If subject is not pregnant, then proceed with the regular follow-up and supplementation schedule for non-pregnant subjects
Prenatal follow-up with subject Bimonthly follow-up during pregnancy Contact subject to inquire on pregnancy progress and subject health status FA07 supplement
Prenatal follow-up with doctor Monthly follow-up during pregnancy Contact subject’s prenatal care provider or abstract from prenatal care records to monitor pregnancy events FA07
Follow-up after miscarriage/stillbirth occurrence Within 60 days of Miscarriage/Stillbirth - Check willingness of subject to resume participation in the study - FA08
- Contact subject’s doctor (if possible) to obtain information about miscarriage/stillbirth event and material - FA09&10
- Check the presence of clefting - FA13
- Photographic documentation
- Complete study termination form if subject is unwilling to continue in the study
Follow up after delivery (live birth) Within 60 days of delivery date - Check delivery events, maternal health behavior during pregnancy, and infant health measures with study subject; check subject’s readiness to resume enrollment in the study - FA11
- Evaluate the infant in person to check for presence of craniofacial or other malformations. - FA12
- Complete study termination form if subject is unwilling to continue in the study - FA21 and FA21 Supplement
- Contact subject’s doctor (if possible) or review medical records to check the presence of craniofacial malformations including clefting and other defects as well as delivery complications; - Photographic documentation - FA13
Post-termination follow up Two months after termination from study Determine whether the subject became pregnant and request consent to contact her prenatal care provider - FA14
- Screening and enrollment After subject agrees to resume enrollment in the study - Follow standard screening, enrollment procedures listed above - FA02
- Verification of B12 and pregnancy, dispensing study pills, and Baseline contact - Subject remains in the original randomization group - FA03
- FA04

Wehby et al.

Wehby et al. BMC Pediatrics 2012 12:184   doi:10.1186/1471-2431-12-184

Open Data