Study Objectives:
The Cymbalta Pregnancy Registry is a prospective, observational study that enrolls
pregnant women prescribed Cymbalta by their health care provider and follows maternal,
fetal, and infant outcomes following exposure to Cymbalta during pregnancy. Data
collected from this study will be shared with the Food and Drug Administration and
may be added to Cymbalta labeling to provide prescribers with additional prescribing
and consulting information.
The objective is to estimate the risk of major congenital anomalies among pregnancies
exposed to Cymbalta, as well as recognized spontaneous abortions, stillbirths, elective
terminations, minor congenital anomalies, and any serious adverse pregnancy outcomes;
the potential impact while breast-feeding is also examined.
Healthcare Provider Participation Steps:
Step 1: Inform patient of Registry so patient can provide consent to initiate
enrollment.
- Click on the
Contact Us
link for how to contact the Registry by phone or e-mail
Step 2: Fill out registration forms to complete enrollment.
- To be eligible for this Registry, the patient must be at least 18 years old, a U.S.
resident, pregnant and have been treated with Cymbalta during pregnancy, and provide
consent
- A woman who has taken one or more doses of Cymbalta while pregnant is eligible.
Sufficient evidence is needed to confirm that Cymbalta exposure occurred during
pregnancy
- No study medication will be given and participation in the registry will not influence
or interfere with the treatment plan recommended by the patient’s healthcare provider
- Registry enrollment is voluntary and initiated by pregnant patients for women exposed
to Cymbalta at any time during pregnancy beginning on or after the first day of
their last menstrual period. Enrollment should occur as early in pregnancy as possible,
preferably before any prenatal testing has occurred
- Enrollment in the Registry is strictly voluntary. The patient can initiate the enrollment
process by calling the Registry and providing verbal consent for participation and
for contacting her healthcare provider(s). Once the patient provides her verbal
consent, data can be collected for enrollment. The patient's obstetric healthcare
provider is then contacted to confirm his or her willingness to provide follow up
regarding the patient's pregnancy. Alternatively, the healthcare provider can initiate
enrollment with a conversation about the Registry with the patient. The healthcare
provider has access to the Registry forms and may consent the patient in his or
her office and send the completed forms to the Registry. Subsequent follow-ups with
the healthcare provider and/or patient will be initiated from the Registry
- Healthcare professionals can obtain registration forms via the Registry website
or by calling the Registry Coordinating Center. All of the Registry forms are in
English and Spanish. Forms can be mailed or faxed to the Registry Coordinating Center
or the data may be provided over the telephone
Step 3: Fill out outcome data forms at specified intervals and provide to
Registry.
- The Registry collects information from the patient at enrollment and confirms it
with the healthcare provider
- Follow-up information is requested from the obstetrical healthcare provider at the
end of the second trimester and the end of the pregnancy
- If a live birth is reported, the Registry conducts follow-up with the infant’s pediatric
healthcare provider at outcome, 4 months, and 12 months of age
- if a birth defect is indicated, the Registry requests additional targeted follow-up
information from the healthcare provider
- If the mother is breast-feeding, a breast-feeding questionnaire is administered to
the mother at 3, 6, 9, and 12 months postpartum while breast-feeding continues
- For details, click on the
Information Collected
and
Data Forms
links