RECRUITINGOBSERVATIONAL

PREHEVBRIO Pregnancy Outcomes Registry

Prospective, Observational, Non-interventional Study Designed to Detect and Describe Pregnancy Outcomes in Women Exposed to PREHEVBRIO® [Pregnancy Outcomes Registry]

About This Trial

The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and analyze information related to post-exposure pregnancy and fetal and neonatal outcomes. The objective of the Registry is to monitor and evaluate all received reports of PREHEVBRIO® vaccine exposure within 28 days prior to conception or at any time during pregnancy and delivery, as well as maternal, obstetrical, pregnancy, fetal and neonatal outcomes. This registry is primarily descriptive and designed to detect potential safety signals rather than test hypotheses.

Who May Be Eligible (Plain English)

Who May Qualify: - Pregnant woman who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. The time of conception will be calculated as the most reliable estimated date of delivery (EDD) minus 38 weeks. For this registry, gestational weeks will be estimated from the EDD or as corrected EDD, if a more reliable EDD (e.g., by ultrasound) is provided. If the EDD is not available or never estimated, the first day of the last menstrual period (LMP) will be used to estimate gestational age and EDD. - The subject provided consent prior to enrollment (for eligible subjects under 18 years old, consent must be obtained from the subject's legally authorized representative). - The subject documents agreement with the release of medical information and contact with her healthcare providers (e.g., PCP, obstetrician, nurse midwife) and the infant's healthcare provider (e.g., pediatrician) for the purpose of collecting medical information. - Reporter's (participant and/or healthcare provider) contact information is available to allow for follow up. Who Should NOT Join This Trial: - Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Pregnant woman who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. The time of conception will be calculated as the most reliable estimated date of delivery (EDD) minus 38 weeks. For this registry, gestational weeks will be estimated from the EDD or as corrected EDD, if a more reliable EDD (e.g., by ultrasound) is provided. If the EDD is not available or never estimated, the first day of the last menstrual period (LMP) will be used to estimate gestational age and EDD. * The subject provided consent prior to enrollment (for eligible subjects under 18 years old, consent must be obtained from the subject's legally authorized representative). * The subject documents agreement with the release of medical information and contact with her healthcare providers (e.g., PCP, obstetrician, nurse midwife) and the infant's healthcare provider (e.g., pediatrician) for the purpose of collecting medical information. * Reporter's (participant and/or healthcare provider) contact information is available to allow for follow up. Exclusion Criteria: * Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.

Treatments Being Tested

OTHER

Data collection

The schedule of office visits and all treatment regimens will be determined by the treating health care provider. No interventions are administered as part of this protocol (observational study).

Locations (1)

ProPharma, Recruiting Nationwide

Overland Park, Kansas, United States