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The AED Pregnancy Registry
- The Massachusetts General Hospital

121 Innerbelt Road ~ Room 220 ~ Somerville, MA ~ 02143 ~ Toll Free: 888-233-2334
Sponsored by: AbbVie, Eisai, Novartis, Ortho-McNeil, Pfizer, Sunovion, UCB
FREQUENTLY ASKED QUESTIONS

FAQ FOR WOMEN

I am already several months pregnant. Can I still enroll in the Registry?
Yes, you can enroll in the Registry at any time during your pregnancy.
Ideally, the Registry would like to enroll women before they reach the 16th week of their pregnancies, but we welcome you to enroll at any time during your pregnancy.

I am taking one of the drugs on your list, but I do not have epilepsy. Can I still enroll in the Registry?
Yes, if you are currently pregnant are taking AEDs for any reason you can enroll in the Registry. Please call (toll free) 1-888-233-2334 to enroll today!

I am a participant in the AED Pregnancy Registry, but I’ve recently moved. Can I still participate?
Yes, you can still participate. Please call us at (toll free) 1-888-233-2334 to update your contact information at your earliest convenience.

How do I update my contact information?
Please call us at (toll free) 1-888-233-2334 to update your contact information at your earliest convenience.

I am pregnant but I am not taking one of the drugs on your list. Can I still enroll in the Registry?
Yes, if you are currently pregnant but not taking AEDs you can enroll in the Registry as a control group participant. A control group can also be called a comparison group. The Registry needs a group of women who are pregnant and are NOT taking anticonvulsant drugs to compare to our group of women who are taking anticonvulsant drugs. This will help us to gather the most accurate data possible for our study. You can find more information about participating in our control group by clicking here. Please call (toll free) 1-888-233-2334 to enroll today!

I recently had my baby, but I have not yet been contacted by the Registry for my post-partum interview. What should I do?
We like to give new moms a few months to rest and settle in with their new babies before we call you for your post-partum interview. However, if it has been more than 3 months since you gave birth, please call us at (toll free) 1-888-233-2334 to check and make sure that we have your correct contact information.

What can you tell me about breastfeeding while taking AEDs?
You can breast feed while taking AEDs, and you should discuss this with your health care provider. A term infant has been exposed to the AED for 9 months and can metabolize the medication as well as an adult, and there is generally less medication in the breast milk than in the mother's plasma. Please see page 1 of the Fall/Winter 2003 issue of our newsletter, and page 3 of the Spring/Summer 2004 issue for more information.

What do I do if I have a question or a concern about participating in the Registry?
Please call us with questions any time. We are more than happy to talk to you about participating in the Registry. Call us at (toll free) 1-888-233-2334.

I am pregnant and taking an AED. Should I stop taking it? Should I decrease my dose?
This is a complicated question, and the answer really varies from woman to woman. Remember, you should never stop or change your medication without the advice and supervision of your health care provider. The danger of seizures to both the mother and the child is a serious one. Seizures can result in falls or in lack of oxygen for the baby. They can increase the risk of miscarriage or stillbirths. For most women with epilepsy, staying on medication poses less risk to their own health and the health of their babies than discontinuing medication. In most cases, a single medication at the lowest possible dose that provides seizure control is the best option.
Please consult with your health care providers about these issues.


I took AEDs while I was pregnant and now I think my child may have some learning or behavioral issues. Is this common? And what should I do?

Research is currently being conducted to determine whether a child who was exposed to anticonvulsant drugs during pregnancy is more likely to experience learning problems during childhood. You can read about this research in our Fall/Winter 2004 issue of the AED Pregnancy Registry Newsletter. The research study that is discussed in the newsletter can be found on the web at www.neuro.mcg.edu/np/NEAD.htm.

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FAQ FOR PROVIDERS

What findings have you released/published?
The AED Pregnancy Registry has released and published information about many AEDs. Please click here for more information about these publications.

Can I access data on a specific drug that my patient is taking even if it hasn’t been released to the general public?
The Registry does not provide any information about certain drugs until they are reviewed and released by the Scientific Advisory Committee. To read more about the methods and release criteria, click here.

Who are your sponsors? Does being sponsored by pharmaceutical companies present a conflict of interest?
The AED Pregnancy Registry is sponsored by Abbott, Eisai, Novartis, Ortho-McNeil, Pfizer and Sunovion.  The Registry is proud to be conducting this research within a non-biased academic setting and goes to great lengths to insure that its research follows scientifically rigorous guidelines in regards to release criteria, anonymity and confidentiality. (For more details, please see our Methods section) 

How many women enroll in the Registry per week?
Currently, approximately 15 women enroll each week.

Are you recruiting controls? How?
We are currently recruiting a control group for the Registry. We are asking Registry participants to ask their pregnant friends or family members (who are not taking AEDs) to enroll in our control group. For more information, please visit the control group section of our web site.

What does the Scientific Advisory Committee do?
The Scientific Advisory Committee is comprised of academic medical researchers with no financial interest in any pharmaceutical corporation. The committee meets twice each year to discuss the analysis of drugs being studied. The committee has final approval over the announcement and publication of registry data and conclusions.


What are your release criteria?
For information about our methods and release criteria, please click here.

Do you provide incentives for the study participant?

We do not provide incentives for most study participants. We do hold a raffle for women who have recruited a friend or family member to particpate as a member of our control group. The referring participant and the control group member each get an entry into the raffle.

How do you ensure confidentiality?
All data is stored in a database without mentioning names. Insurance companies, providers, and the pharmaceutical firms supporting the Registry DO NOT have access to any of this information.

What can you tell me about breastfeeding while taking AEDs?

Women can safely breast feed while taking AEDs. A term infant has been exposed to the AED for 9 months and can metabolize the medication as well as an adult, and there is generally less medication in the breast milk than in the mother's plasma. Please see page 1 of the Fall/Winter 2003 issue of our newsletter, and page 3 of the Spring/Summer 2004 issue for more information.

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FAQ FOR PRESS

When was the Registry started?
The North American AED (antiepileptic drug) Pregnancy Registry was estab
lished in 1997.

How many women have enrolled?
As of September 2011, 8,200 women have enrolled in the Registry.

Where are these women from?
The participants of the Registry represent all 50 United States and all 10 Provences in Canada.

What drugs are included in the study?
For a list of drugs that are included in the Registry, please see our Providers page.

How many women with epilepsy are taking these medications?
In the United States alone there are an estimated 1.1 million women with epilepsy of child bearing age.

Who should I contact if I’d like to write an article about the AED Pregnancy Registry?
Please contact Caitlin Smith, M.P.H. (Senior Project Manager) at crsmith1@partners.org, or (617) 726-7739.

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