Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA)
Recruitment status was Recruiting
Fertile women postpone their wish to conceive when they have active disease activity of rheumatoid arthritis (RA). Since treatment options are restricted and inappropriate in many women with high disease activity, an observational study among fertile women with a wish to conceive, treated with a regular care program, among which a consultation of gynecologist and a rheumatologist will be provided, in order to enlarge the chance of conceiving. Treatment options will be discussed with the patient, and when needed TNFalfa inhibitors will be prescribed until 20th week of gestation. Follow-up of disease activity of RA, complications of treatment, and pregnancy outcome of women are part of the observational study. As well as the observational study on the newborn on activity of TNFalfa inhibitors in (cord)blood, growth analysis and general health.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Preconception Counselling for Women With a Pregnancy Wish and High Disease Activity of Rheumatoid Arthritis (RA) With a Prospective Observational Study Addressing Health Issues of Mother and Child.|
- number of pregnancies [ Time Frame: 2 years ] [ Designated as safety issue: No ]Percentage of women that become pregnant during 2 year period of time, with accurate controlled disease activity of RA.
- health of newborn exposed to TNFalfa inhibitors [ Time Frame: 3 years ] [ Designated as safety issue: No ]Development (growth and health) of newborns exposed to TNFalfa in utero / early in pregnancy.
Biospecimen Retention: Samples With DNA
blood of mother before, during and after pregnancy cordblood of newborn blood of newborn
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345071
|Contact: Y A de Man, PhD MDfirstname.lastname@example.org|
|Contact: J MW Hazes, Prof PhD MDemail@example.com|
|ErasmusMC, University Medical Center Rotterdam, dept. of Rheumatology||Recruiting|
|Rotterdam, Netherlands, 3000CA|
|Sub-Investigator: Y. A. de Man, PhD, M.D.|
|Principal Investigator: Johanna MW Hazes, Prof. dr.|
|Principal Investigator:||Johanna MW Hazes, Prof. dr.||Head of department|