The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.
Study Type
OBSERVATIONAL
Enrollment
1
Up0019 001
Wilmington, North Carolina, United States
Percentage of newborns with major congenital malformations
The prevalence of major congenital malformations (MCMs) reported will be calculated by dividing the number of offspring with MCMs by the total number of live births and fetal losses with an MCM for all enrolled pregnancies and then stratified by treatment during pregnancy. The prevalence of MCMs will be calculated as soon as there are at least 50 prospectively-enrolled patients with an available outcome. Stillbirths and induced abortions (at 20 weeks gestation or greater) with reported MCMs are included in the estimate of the MCM prevalence.
Time frame: At 20 weeks gestation or greater
Percentage of pregnancy outcomes with major congenital malformations
The pregnancy outcomes with and without MCMs will be summarized using frequency counts by all trimesters of exposure and earliest trimester of exposure.
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Numbers of maternal pregnancy-related events
Descriptive statistics will be presented for the numbers of maternal pregnancy-related adverse events (AEs), adverse birth. Frequencies and proportions of adverse pregnancy will be presented using descriptive statistics. Analyses may include (but are not limited to) stratification by trimester of exposure, gestational age at time of consent, maternal age, and geographic region.
Time frame: During pregnancy up to Week 40
Percentage of Vaginal and C-section deliveries
Time frame: At birth (Day 0)
Gestational age at birth
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Birth weight
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
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Small for gestation age
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Percentage of adverse events in infants
Percentage of adverse events (AEs) being collected in infants at study follow-up period (first 18 months)
Time frame: Within the first 18 months of life
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Time frame: 18 months