Asthma
Conditions
Brief summary
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. The evaluation of infants will be conducted at birth and at 6-month intervals until the infants are 12 months old. Follow-up of the infant will be extended until the infant is 18 months old, if the woman continues Xolair® treatment while breastfeeding.
Interventions
DRUGXolair®
This being an observational study, the study protocol does not specify any dose regimen.
Sponsors
Novartis
Genentech, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
\- Women who have been exposed to at least one dose of Xolair® (whether inadvertent or deliberate) within 8 weeks prior to conception or during pregnancy
Exclusion criteria
* Women not currently pregnant * Women exposed to Xolair® not during pregnancy but only while breastfeeding * Re-enrollment of women who are pregnant for second (or more) time is not allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Live Births | At Delivery (up to approximately 9 months after enrollment) |
| Number of Elective Terminations | At Delivery (up to approximately 9 months after enrollment) |
| Number of Fetal Deaths or Stillbirths | At Delivery (up to approximately 9 months after enrollment) |
| Number of Congenital Birth Anomalies | At Delivery (up to approximately 9 months after enrollment) |
Secondary
| Measure | Time frame |
|---|---|
| Apgar Score of Neonates/Infants | Delivery (up to approximately 9 months after enrollment) to 18 months |
| Number of Infant Illnesses or Infections | Delivery (up to approximately 9 months after enrollment) to 18 months |
| Neonatal Platelet Count | Delivery (up to approximately 9 months after enrollment) to 18 months |
| Number of Pregnancy Complications or Abnormalities | Up to approximately 9 months after enrollment |
| Length of Neonates/Infants | At Delivery (up to approximately 9 months after enrollment) |
| Head Circumference of Neonates/Infants | At Delivery (up to approximately 9 months after enrollment) |
| Weight of Neonates/Infants | At Delivery (up to approximately 9 months after enrollment) |
| Number of Spontaneous Abortions | At Delivery (up to approximately 9 months after enrollment) |
| Number of Delivery Complications or Abnormalities | At Delivery (up to approximately 9 months after enrollment) |
| Gestational Age of Neonates/Infants | Up to approximately 9 months after enrollment |
Countries
United States
Outcome results
None listed