The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.
This pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and health care providers throughout North America. Participants in the first two cohorts are recruited concurrently from callers to OTIS centers, from health care providers and through direct to consumer marketing efforts. The source of historical controls is archived data on pregnancies that have been followed through the California Teratogen Information Service's Clinical Research Program located at the University of California San Diego.
Study Type
OBSERVATIONAL
Enrollment
830
Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study.
Research Site
San Diego, California, United States
Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Time frame: From birth through 1 year of age
Percentage of Infants With Major Birth Defects in All Pregnancies
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Time frame: From birth through 1 year of age
Percentage of Infants With Any 3 or More Minor Birth Defects
A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Time frame: From birth through 1 year of age
Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects
A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From birth through 1 year of age
Percentage of Pregnancies Ending in Spontaneous Abortion
Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event.
Time frame: 9 months
Percentage of Participants With Pre-term Delivery
A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks' gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded.
Time frame: 9 months
Gestational Age at Delivery (GAD) of Live Births
Time frame: At birth
Birth Weight Among Full Term Infants
Time frame: At birth
Birth Length Among Full Term Infants
Time frame: At birth
Birth Head Circumference Among Full Term Infants
Time frame: At birth
Percentage of Infants With Small for Gestational Age Birth Weight
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
Time frame: At birth
Percentage of Infants With Small for Gestational Age Birth Length
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
Time frame: At birth
Percentage of Infants With Small for Gestational Age Birth Head Circumference
Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.
Time frame: At birth
Postnatal Weight Percentile at One Year
Time frame: 1 year after birth
Postnatal Length Percentile at One Year
Time frame: 1 year after birth
Postnatal Head Circumference Percentile at One Year
Time frame: 1 year after birth
Percentage of Infants at One Year of Age With Small for Gestational Age Weight
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
Time frame: 1 year after birth
Percentage of Infants at One Year of Age With Small for Gestational Age Length
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
Time frame: 1 year after birth
Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference
Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.
Time frame: 1 year after birth
Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year
Time frame: From birth to 1 year
Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age
Time frame: From birth to 1 year
Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)
The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: "Yes," "Sometimes," "Not Yet," with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported.
Time frame: 1 year after birth