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Table 5 Schedule B (Data collection after detection of menstruation delay or pregnancy)

From: Oral cleft prevention program (OCPP)





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


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