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 |
| Â | Â | - 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 |
| Â | Â | Obtain blood samples for a folate testing (if applicable). | - FA06 (if pregnancy is confirmed) |
| Â | Â | - If pregnancy is confirmed, calculate gestational age and advise subject as when to stop taking the study pills | Â |
| Â | Â | - If subject is not pregnant, then proceed with the regular follow-up and supplementation schedule for non-pregnant subjects | Â |
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 |
| Â | Â | - Check the presence of clefting | - FA13 |
| Â | Â | - Photographic documentation | Â |
| Â | Â | - Complete study termination form if subject is unwilling to continue in the study | Â |
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 |
| Â | Â | - Evaluate the infant in person to check for presence of craniofacial or other malformations. | - FA12 |
| Â | Â | - 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 | Â | - Subject remains in the original randomization group | - FA03 |
- FA04 |