Pregnancy Exposure Registry for AVONEX
Summary
This is an observational, exposure-registration and follow-up study, which will be conducted in the United States (US). The AVONEX® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses inadvertently exposed to AVONEX® and to detect any potential increase in the risk of major birth defects. It is also designed to detect any potential increase in the risk of spontaneous pregnancy loss. The AVONEX® Pregnancy Exposure Registry is sponsored by Biogen Idec Inc. and will be managed by Kendle, the Registry Data Coordinating Center (DCC). The Registry will be monitored by an independent Advisory Committee consisting of external experts in relevant specialities of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).
Description
Prospective reports will be collected from pregnant subjects, health care providers (HCPs), or Biogen Idec Drug Safety and Risk Management (DSRM) staff. Data from pregnant subjects will be collected at 4 to 5 months of pregnancy and 8 to 12 weeks after the estimated date of delivery (EDD) by telephone interviews with the Registry. The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry, paper forms mailed/faxed to the Registry, electronic forms/queries sent to the Registry, or a combination of these methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric Follow-Up at 8 to 12 weeks age. If a birth defect is reported, targeted follow-up will be conducted.
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Pregnancy
Location
Kendle
Wilmington
North Carolina
United States
28405
Status
Recruiting
Source
Biogen Idec
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00168714
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pregnancy Proteins
Proteins produced by organs of the mother or the PLACENTA during PREGNANCY. These proteins may be pregnancy-specific (present only during pregnancy) or pregnancy-associated (present during pregnancy or under other conditions such as hormone therapy or certain malignancies.)
Pregnancy In Diabetics
The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.
Pregnancy, Unplanned
Unintended accidental pregnancy, including pregnancy resulting from failed contraceptive measures.
Pregnancy, High-risk
Pregnancy in which the mother and/or FETUS are at greater than normal risk of MORBIDITY or MORTALITY. Causes include inadequate PRENATAL CARE, previous obstetrical history (ABORTION, SPONTANEOUS), pre-existing maternal disease, pregnancy-induced disease (GESTATIONAL HYPERTENSION), and MULTIPLE PREGNANCY, as well as advanced maternal age above 35.
Diabetes, Gestational
Diabetes mellitus induced by PREGNANCY but resolved at the end of pregnancy. It does not include previously diagnosed diabetics who become pregnant (PREGNANCY IN DIABETICS). Gestational diabetes usually develops in late pregnancy when insulin antagonistic hormones peaks leading to INSULIN RESISTANCE; GLUCOSE INTOLERANCE; and HYPERGLYCEMIA.
Clinical Trials
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Usefulness of Home Pregnancy Testing
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Risk Factors of Ectopic Pregnancy
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The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.
PubMed Articles
Pregnancy complicating systemic lupus erythematosus: a series of 86 cases.
OBJECTIVE: To investigate the timing of pregnancy and pregnancy termination and its management in women with pregnancy complicating systemic lupus erythematosus (SLE). METHODS: A series of 86 cases of...
Changes in the liver biochemical profile are normal in pregnancy. However, up to 3% to 5% of all pregnancies are complicated by liver dysfunction. It is important that liver disease during pregnancy i...
Outcomes of pregnancy following postpartum haemorrhage.
OBJECTIVE: To assess the outcomes of pregnancy following postpartum haemorrhage (PPH) in the first pregnancy. DESIGN: Cohort study. SETTING: Aberdeen Maternity Hospital, Scotland, UK. POPULATION: All...
The mother-offspring dialogue begins even before implantation and is essential to signal pregnancy, establish robust contact, and maintain embryo growth and development. Any circumstance that disrupts...
Predictors of the use of medications before and during pregnancy.
Background Drug use in pregnancy is often reason of concern for mothers and their physicians. However, only few studies investigated predictors of drug use in pregnancy. Objectives To examine maternal...
