The Cymbalta Pregnancy Registry

Study Overview
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Brief Summary
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The Cymbalta Pregnancy Registry is a U.S. based Registry designed to monitor women who are exposed to Cymbalta (duloxetine) during pregnancy. This is an observational, exposure-registration and follow-up registry.

Official Title
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The Cymbalta Pregnancy Registry

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient evidence (e.g., date or gestational age) to confirm that Cymbalta exposure occurred during pregnancy Sufficient data to establish in which trimester of pregnancy the exposure to Cymbalta first occurred (i.e., first, second or third trimester) Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the Registry) Date the pregnancy exposure is reported to the Registry Source of the report (Health Care Professional or pregnant patient) Full contact information for the reporter and Health Care Professional willing and able to provide accurate pregnancy-related information (name, address, phone number, etc.) Exclusion Criteria: Reported cases that do not meet the minimum criteria for Registry enrollment are deemed ineligible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant patients exposed to Cymbalta<br>Pregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period | Drug: duloxetine<br>* any exposure to duloxetine that occurred during pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta |  | maximum of 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate risk of recognized spontaneous abortions, stillbirths, elective terminations, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Cymbalta and their live births during the first year of life |  | maximum of 22 months | 
| To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life |  | maximum of 22 months | 
| To compare the risk of major congenital anomalies among pregnancies exposed to Cymbalta to an appropriate comparator(s) such as the Centers for Disease Control and Prevention (CDC) Metropolitan Atlanta Congenital Defects Program (MACDP) |  | maximum of 22 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, pregnant, Cymbalta, Pregnancy Outcomes