Facts About Joining a Registry

What is a pregnancy registry?

A registry is a database that collects information on people with specific health conditions. The information can be used to help improve patient care, public health initiatives and research overall.

A pregnancy registry is no different. “Typically, pregnancy registries that are established here or elsewhere in the world are often focused on looking at a particular treatment or set of treatments that might be used for an underlying condition,” said Christina Chambers, Ph.D., MPH, associate director of the Altman Clinical & Translational Research Institute at the University of California, San Diego.

The data collected during a pregnancy registry can be life changing for people living with a chronic illness — especially people with multiple sclerosis (MS).

“People with chronic conditions like MS present a number of challenges in terms of the best treatment and providing the best health outcomes. And then when it comes to pregnancy, there’s a whole set of other questions that come up,” Chambers said.

Read: FAQs About MS >>

Pregnancy registries and MS

MS is an autoimmune condition that affects your brain and spinal cord. Most women and people assigned female at birth (AFAB) are diagnosed with MS in their reproductive years but research is lacking when it comes to MS and pregnancy. This is because historically disease-modifying therapy trials didn’t include pregnant people. So, if you were enrolled in a trial, you had to quit if you got pregnant.

For a long time, people with MS were told not to get pregnant at all because treatments could potentially harm the unborn child. It wasn’t until 2002 that the FDA required drug manufacturers to create pregnancy registries for people with MS to help gather information on the effect of disease modifying therapies before, during and after pregnancy. The registries also record outcomes including miscarriages and birth defects. In other words, is the medication safe for pregnancy?

“It’s one of the reasons why we do pregnancy registry studies — so people who either find out they’re pregnant or taking the drug or were considering taking it in a future pregnancy can feel relatively reassured that there isn’t evidence to suggest [harm],” Chambers said.

We now know that people with MS can have healthy pregnancies. In fact, studies show that the rate of birth defects are about the same for people with MS compared to people without MS.

Still, there’s little information on the effects of disease modifying therapies and other medications on pregnancy for people with MS. The lack of research overall has left a huge gap in accessible data and many of the newer medications are still in research phases regarding safety and side effects during pregnancy.

Read: When Treating Multiple Sclerosis, Shared Decision-Making Matters >>

How to sign up for a registry

Joining a registry can help fill these gaps in information. Chambers noted that different registries have different requirements. Some registries only collect reporting from healthcare providers. Others rely on a combination of reporting from the pregnant person and information from the provider. “All of the ones that we do — and many other ones as well — consider the mother the primary source,” Chambers said.

How and when to sign up can also vary per registry. In many cases, a neurologist or HCP will refer the person to a registry. From there, it’s up to that person to contact the registry and ultimately decide if it’s a good fit. Also, online resources such as MotherToBaby, MSBase Registry and the National Multiple Sclerosis Society can help connect people to open registries. Drug manufacturers may also promote pregnancy registries online.

Chambers said it’s important to learn everything you can early on about the registry and ask questions about the time commitment — some studies can go on for years — and what’s expected from you during that time.

Pregnancy registries and privacy

It’s also important to know who your information will be shared with.The issue of privacy and confidentiality is a valid concern when you’re sharing important details like medical records and personal information. But Chambers said part of the consent process for a registry includes how confidentiality is being protected, how the data is being stored and that no identifiable information is shared outside the staff working on the study. “So nobody could go say, ‘Mrs. So-and-so took part in the study’ — that would not happen,” Chambers said. “[The participant] can feel assured that she’s not going to see her picture or her name in a paper and that her identity is protected throughout the study.”

The one exception is if someone wanted to be part of a testimonial after participating in a registry. But, again, that’s up to the person in the study.

Women helping women

Pregnancy registries provide an opportunity to help other people with MS make educated decisions about pregnancy and treatment. The information collected can even impact decisions made long before a pregnancy is confirmed. That’s pretty powerful stuff. “We hear that over and over again … people saying I’m doing this because I wish I had known or I wish I had this information so I want to make sure that the next person does have it,” Chambers said. “The mom’s who do it — they’re amazing. They are contributing their time and their personal information. It’s a really gracious thing that they do.”

This educational resource was created with support from Novartis, a HealthyWomen Corporate Advisory Council member.