Table 7 Secondary outcome measures

Serum/red cell folate levels

Measured using appropriate equipment (e.g. the Elecsys 2010 (Roche) or Immulite 2000) and reported in ng/ml.

Recurrence and severity of CL/P

A severity score will be generated based on Table 6 above and the classification reported in Additional file 1

Occurrence of twinning

Greater than 1 fetus per current pregnancy

Occurrence of a miscarriage/spontaneous abortion

Fetal loss before 20 weeks of pregnancy

Incidence of Preeclampsia

As reported according to local obstetric standards

Occurrence of other birth defects

As diagnosed by clinical exam.

Birth Weight of the baby

As measured at birth (in grams)

Gestational age at birth

As determined by the obstetrician (in weeks-days)