- About 50% of all U.S. pregnancies are unplanned.
- Many women enter pregnancy with medical conditions that require
medical treatment.
- New medical problems may develop or old ones may worsen due
to pregnancy.
- It is common for pregnant women to take medication during
the critical period of fetal development because
- The woman is unaware of her pregnancy.
- It may be medically necessary to continue treatment throughout
pregnancy.
In response to these facts, FDA began requiring some pharmaceutical
manufacturers to conduct pregnancy exposure registries. The
results of these studies will provide pregnant women and their
health care providers' better understanding of drug effects
on fetal health. FDA/OWH developed a master directory of pregnancy registries to aid pregnant women who are taking medications to participate in these important studies.
What is a pregnancy exposure registry?
FDA defines a pregnancy exposure registry as a prospective
observational study that collects information on women who
take medicines and vaccines during pregnancy.
Enrollment requires that the health of the baby be unknown
to reduce bias. Data collected on babies born to women taking a particular medicine
are compared with babies of women not taking the medicine.
These studies provide important information the effect medicines
have on fetal development
How can you participate in a pregnancy exposure registry?
Contact the pregnancy
exposure registry you are interested in to find out
what you need to do to sign up.
Some registries may require you to enroll through your health
care provider (doctor, nurse, or pharmacist). The * symbol on the registry list means your doctor will enroll you.
What should you expect when you participate?
Participation requires a few interviews during and after your
pregnancy. The information collected during these interviews,
as well as the fact of your participation, will be kept confidential.
The outcome of your pregnancy--and that of the other participants
in the study--will be analyzed periodically. The pregnancy
registry contact can tell you if reports of these analyses
are available and how to obtain them.
Please Note: All medication use should be discussed with your
doctor. Please speak with a health-care provider who knows
you, your condition, and your medicine before making any decision
about the use of medical products during pregnancy.
To have your pregnancy exposure registry listed on this
site, please contact the Office of Women's Health at Registries@fda.hhs.gov or
at 301-827-0350. |
