P04.1
Conditions
Interventions
Group 1: Study part 1: maternal exposure to TNF-a blockers
exposure time meets any time from last menstrual period (LMP) until week 12+0 after LMP. Exposure may have started earlier than LMP and can have continued beyond week 12.
Study part 2: maternal expos
exposure time either took place before the 20th week of gestation or meets any time beyond week 20 after LMP. Exposure may have started earlier in pregnancy
at least one injection after week 20+0 and before delivery is obligatory. The pregnancy may have been included in the study part I, but need not and can be retrospectively ascertained shortly after bi
randomly chosen from the same data pool as the exposed.
Study part 2: prospective long-term follow-up
noTNF-alpha blocker therapy or other biologics. Per exposed two control children matched for infant's sex, gestational week at birth, birth weight (+/-100g) and year of birth.
Sponsors
Pharmakoivigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1: Prospectively ascertained pregnancies with first trimester exposure to adalimumab, certolizumab pegol, etanercept, golimumab or infliximab. Maternal therapy might have started earlier and can last longer. Comparison group: prospectively ascertained pregnancies without exposure to adalimumab, certolizumab pegol, etanercept, golimumab or infliximab (or other biologics). Part 2: Prospective ascertainment of long-term follow-up of children being at least 1-year-old or older. They must have been exposed in utero to at least one maternal injection of the named TNF-alpha blockers. Comparison children: Prospective ascertainment of long-term follow-up of children being at least 1-year-old or older matched for sex, gestational week at birth, birth weight and year of birth. No TNF-alpha blockers (or other biologics) during pregnancy.
Exclusion criteria
Exclusion criteria: Excluded from all cohorts are pregnancies with: major teratogens (acitretin, isotretinoin, mycophenolate, thalidomide, valproiic acid) or/and major fetotoxic agents (ACE-inhibitors or sartans when used in 2nd and/or 3rd trimester) or/and acute malignancies. For study part 2: Excluded are children with malformations having an impact on normal development and preterms born before week 34 0/7.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Eight weeks after the estimated date of birth a structured questionnaire is sent to the mother /physician. Primary endpoints are delivery of the child with /without anomalies, spontaneous abortion, and elective termination of pregnancy. Part 2: For children being one year or older, an extra questionnaire designed for this study, will be sent to the mothers dealing with infant development within the first year of life. Primary objectives are frequency and severity of infections, allergies and reactions to vaccines. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: prematurity, birth weight Part 2: infant's weight gain, achievement of developmental milestones | — |
Countries
Australia, Finland, France, Germany, Italy, Netherlands, Switzerland, Turkey, United Kingdom
Contacts
Public ContactCorinna Weber-Schoendorfer
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Outcome results
None listed