The Cymbalta® Pregnancy Registry

What information is collected by the Registry?

The Registry collects information from the patient at enrollment and confirms it with the health care provider. Follow-up information is requested from the obstetrical provider at the end of the second trimester and the end of the pregnancy. Additional information is requested from the pediatric provider at birth, 4 months, and 12 months. The patient is also contacted for breastfeeding information at 3, 6, 9, and 12 months after birth, as applicable.

Information Collected:

Maternal demographic information, reproductive history, concurrent medical conditions, and concomitant medications/exposures

Prenatal testing information

Health Care Provider contact information

Cymbalta therapy information (daily dose, start date, stop date relative to conception, etc.)

Familial history of birth defects

Pregnancy outcome information (live birth, stillbirth, miscarriage, etc.)

Infant birth data and findings

Assessment of infant growth and development and physical exam findings at 4 months and 12 months

Breastfeeding assessment at 3, 6, 9, and 12 months

Because this Registry is an FDA required post-marketing safety study, it is exempt from HIPAA regulations (45 CFR-164.512). The Registry does require an abbreviated consent document, which is completed by a clinical research associate over the phone (i.e., an authorization for release of medical information and release forms). The IRB has granted a waiver of documentation of informed consent, allowing patients to provide this verbal consent to participate without a written signature.

How are data collected by the Registry?

Enrollment in the Registry is voluntary and can be initiated by the patient or her health care provider by contacting the Registry.

In order for the Registry to collect the best data possible, it is extremely important for eligible patients to be enrolled early in pregnancy, preferably before any prenatal testing has been conducted. However, eligible patients at any trimester of pregnancy may enroll.

Data is collected by the Registry Coordinating Center on Registry data collection forms. Click on contact us for more information about contacting the Registry Coordinating Center.

How are data analyzed and reported?

The Registry plans to produce an interim report for participating Health Care Providers every 12 months to share the most current information from this ongoing Registry. This reporting schedule is contingent upon the level of enrollment. The interim report will continue to evolve as more data are collected and analyzed.

An important aspect of The Cymbalta Pregnancy Registry is the Scientific Advisory Board (SAB) formed to oversee the collection and analysis of Registry data and the presentation of results. This independent SAB is composed of recognized experts in the fields of teratology, epidemiology, maternal and fetal medicine, and therapeutic areas of interest, from the CDC, academia, and private practice. The Committee’s membership also includes non-voting representatives from Eli Lilly and Company and Kendle International Inc. The SAB will advise on the Registry, as well as review and provide interpretation and reporting of the cumulative data on an ongoing basis.

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