The safety of anti-tumor necrosis factor-alpha (TNF-a) agents in pregnancy. An observational prospective multicenter study.
- Conditions
- P04.1Fetus and newborn affected by other maternal medication
- Registration Number
- DRKS00005036
- Lead Sponsor
- Pharmakoivigilanz- und Beratungszentrum für Embryonaltoxikologie, Charité Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 625
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.
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>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.<br>
- Secondary Outcome Measures
Name Time Method Part 1: prematurity, birth weight<br>Part 2: infant's weight gain, achievement of developmental milestones