Pregnancy outcome after rheumatologic methotrexate (MTX) treatment prior to or during early pregnancy: a prospective multicenter cohort study (Rheumatologic MTX treatment and pregnancy outcome)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  METHOTREXATE

Population studied

• Short description of the study population:
  Women on MTX (≤30mg/week) either in the post-conception period or within 12 weeks before conception.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1450

Study design details

• Main study objective:
  To assess the risk of low-dose methotrexate (MTX) exposure in early pregnancy.
• Outcomes:
  Rate of major birth defects, rate of specific MTX embryopathy, rate of spontaneous abortion, rate of elective terminations of pregnancies, birth weight, rate of prematurity, Definition of a "teratogenic time window", Evaluation of teratogenic dose-effect relationship.
• Data analysis plan:
  Birth defect rates include live births and anomalies in elective terminationsof pregnancies (ETOPs) and miscarriages. For calculating rates ofmajor birth defects possibly associated with a teratogen, welldefinedgenetic syndromes are excluded. See: Schaefer C, Ornoy A, Clementi M, Meister R, Weber-Schoendorfer C. Using observational cohort data for studying drug effects on pregnancy outcome--methodological considerations. Reprod Toxicol. 2008,26:36-41. For calculation spontaneous abortion rate see Meister R, Schaefer C. Statistical methods for estimating the probability ofspontaneous abortion in observational studies--analyzing pregnancies exposed to coumarin derivatives. Reprod Toxicol. 2008,26:31-5