PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

Exclusion Criteria

• •Trying to conceive for ≥6 months (as \~90% of pregnancies occur after 6 months of trying);
• •Diagnosed ovulatory disorders (polycystic ovary syndrome, endometriosis, or menstrual irregularity);
• •More than 2 miscarriages in the past year;
• •Undergoing fertility assistance (including current IVF or intrauterine insemination);
• •Pre-existing medical condition known to impact maternal folate status (malabsorptive and inflammatory bowel diseases, active celiac disease, gastric bypass surgery, type 1 or 2 diabetes mellitus);
• •Lifestyle factors known to impact maternal folate status (current smoking, \>6 alcoholic drinks per week, recreational drug use);
• •On the female or male side of those trying to conceive: personal NTD history, previous NTD-affected pregnancy, or personal or family history of other folate sensitive congenital anomalies;
• •Use of folate-inhibiting medications (Chloramphenicol, Methotrexate, Metformin, Sulfasalazine, Phenobarbital, Phenytoin, Primidone, Triamterene, Barbiturates).