Dec, 6 2025
When a woman finds out she’s pregnant, one of the first questions she asks isn’t about nursery colors or baby names-it’s about the pills she’s been taking. Pregnancy registries are the quiet, behind-the-scenes system trying to answer that question with real data, not guesswork. These aren’t clinical trials. They’re not testing new drugs. They’re watching what happens when women take medications they were already using-antidepressants, seizure meds, autoimmune biologics-and carry a baby to term. The goal? To find out if those drugs might harm the developing baby.
Why Do We Even Need These Registries?
Before a drug hits the market, it’s tested in thousands of people. But pregnant women are almost always left out. Ethical concerns, legal risks, and fear of harming a fetus mean clinical trials skip this group entirely. That leaves doctors and patients flying blind. An estimated 80% of pregnant women in the U.S. take at least one medication during pregnancy. Some are for chronic conditions-epilepsy, diabetes, depression. Others are for short-term issues like infections or nausea. But without data, we don’t know if those drugs are safe. That’s where pregnancy registries come in. They started gaining traction after the thalidomide disaster in the 1960s, when a drug prescribed for morning sickness caused severe birth defects in thousands of babies. Since then, regulators like the FDA and EMA have required companies to set up registries for certain drugs, especially those likely to be used by women of childbearing age. These aren’t optional. They’re part of the approval process.How Do Pregnancy Registries Actually Work?
Think of them as long-term watchlists. Women who are pregnant and taking a specific medication can volunteer to join. They’re contacted early in their pregnancy-sometimes even before they know they’re expecting-by a registry coordinator. They answer detailed questions: What drug? When did you start taking it? How much? Are you taking anything else? Do you smoke? Drink? Have diabetes or high blood pressure? Then, they’re followed throughout the pregnancy. After birth, researchers track whether the baby has any birth defects, was born early, weighed too little, or had other complications. Some registries go further-tracking development at 6 months, 12 months, even into toddlerhood to check for learning delays or behavioral issues. The National Pregnancy Registry for Psychiatric Medications, for example, follows kids up to age one to assess neurodevelopment. Unlike passive systems that just collect reports of side effects, registries actively recruit participants and collect data in real time. That means less guesswork. No relying on a mother’s memory months later. No missing doses or misremembered dates. This kind of data is gold for researchers.What Have We Learned So Far?
The data isn’t perfect, but it’s changing practice. For example, registry data helped confirm that certain antiseizure drugs like valproate carry a high risk of neural tube defects and cognitive delays. That’s led to clear warnings: avoid valproate in pregnancy if possible. Other drugs, like some SSRIs used for depression, showed no major increase in birth defects in registry studies-giving anxious moms some reassurance. For newer biologic drugs used in autoimmune diseases like rheumatoid arthritis or psoriasis, registries have been the only source of safety data. Drugs like adalimumab and certolizumab were once total unknowns in pregnancy. Now, data from registries show they cross the placenta minimally, especially if taken in the third trimester. That’s led to updated guidelines: many women can safely continue these meds during pregnancy. But here’s the catch: we’re still missing answers for a lot of drugs. There are over 80 active registries in the U.S. alone, covering psychiatric meds, antiepileptics, and biologics. But many drugs-especially older ones or those used for rare conditions-still have no registry at all. And even when registries exist, they’re often too small to catch rare risks.
The Limits: Why Registries Can’t Give You a Guarantee
No registry can say, “This drug is 100% safe.” That’s not how science works. They’re designed to detect big risks-not small ones. Let’s say a birth defect normally happens in 1 out of 100 babies. If a drug doubles that risk to 2%, you’d need over 1,200 exposed pregnancies to spot it with confidence. Most registries enroll far fewer than that. Some have only 50 to 200 women. Another problem? Who joins? Enrollment is voluntary. Only about 15-20% of eligible women sign up. Those who do are often more anxious, more informed, or more motivated to help science. That means the data might not represent everyone. A woman who skips the registry might be the one who’s less worried, less likely to follow up, or already had a bad outcome. That’s selection bias. And even when data comes in, it takes years. A registry might run for 3 to 5 years just to collect enough cases. By then, the drug might have been on the market for a decade. That’s why experts say registries are best for spotting signals-not giving final answers.What’s Changing? The Future of Pregnancy Safety Data
The field is evolving. In 2022, the FDA launched the Pregnancy Safety Research Network to link up multiple registries and standardize how data is collected. That means more power to detect trends. In 2024, the National Pregnancy Registry for Psychiatric Medications added 18 new drugs, bringing its total to 45. That’s progress. But the real shift is in combining methods. Experts now say registries should be just one piece of the puzzle. They’re paired with large health databases-insurance claims, electronic medical records-that can track tens of thousands of pregnancies. These databases have big numbers but messy data: did the mom actually take the pill? Was the dose right? Registries fix those gaps. The goal isn’t to replace one system with another. It’s to layer them. Use registries to find a red flag. Then use big data to confirm it. Use big data to find a pattern. Then use a registry to dig deeper.What It Feels Like to Join a Registry
For the women who sign up, it’s not just science-it’s personal. Many are terrified. They’ve been told their medication might hurt their baby. They’ve been told to stop it, even if it means worsening their own health. Joining a registry gives them a way to take action. They’re not just passive patients. They’re contributors. MotherToBaby, which runs several registries, found that 78% of women who participated felt they made a difference. They appreciated getting personalized updates, even if the news wasn’t always good. But it’s not easy. Some women drop out. Pregnancy is exhausting. Appointments pile up. Some feel overwhelmed when they can’t get a quick answer. “I just wanted to know if my baby would be okay,” one participant told researchers. “But they said, ‘We’re collecting data. We’ll let you know in a year.’” Still, many say it’s worth it. They feel less alone. They know their experience helps other women down the line.
Who Runs These Registries? And How Much Do They Cost?
Pharmaceutical companies are required to fund them. A single registry can cost between $500,000 and $2 million a year. That covers staff, outreach, data entry, follow-ups, and reporting to regulators. It’s expensive. That’s why only the most widely used or highest-risk drugs get registries. Registries are run by academic medical centers, hospitals, or nonprofit groups like MotherToBaby, often in partnership with drug makers. The FDA and EMA oversee them. Every year, sponsors must submit safety reports. Findings are published in medical journals once enough data is collected. The global market for pregnancy safety monitoring-registries and other tools-is worth nearly $300 million and growing. That’s because regulations are tightening. In the last five years, 65% of new biologics approved by the FDA came with a pregnancy registry requirement.What Should You Do If You’re Pregnant and on Medication?
Don’t stop your meds without talking to your doctor. That’s the biggest risk. Untreated depression, uncontrolled seizures, or active autoimmune disease can be far more dangerous to your baby than most medications. Ask your provider: Is there a registry for this drug? Can I join? Even if you don’t join, ask what the current data says. Many registries have public summaries you can read. If you’re considering pregnancy, check if your meds are on a registry list. Some websites, like MotherToBaby.org, offer free, evidence-based advice. They’re not a substitute for medical care-but they’re a solid starting point.Final Thoughts: Registries Are a Lifeline, Not a Crystal Ball
Pregnancy registries don’t give you certainty. But they give you something better: evidence. They turn fear into facts. They turn silence into answers. For women on long-term medications, they’re the only reason we know that some drugs are safer than we thought. For others, they’re the reason we now know to avoid certain ones. They’re not perfect. They’re slow. They’re small. But without them, we’d be making decisions in the dark. And that’s a risk no pregnant woman should have to take alone.Are pregnancy registries mandatory for all medications?
No. Registries are typically required only for drugs that are likely to be used by women of childbearing age, especially newer biologics, psychiatric medications, and antiepileptics. The FDA and EMA require them as part of post-marketing commitments when pre-approval data is limited. Most older or low-risk medications do not have active registries.
Can a pregnancy registry tell me if my specific medication is safe for my baby?
Not definitively. Registries look for patterns across many pregnancies. They can tell you if a drug is linked to a higher risk of certain birth defects-but they can’t predict outcomes for an individual. A negative result means the risk is likely low, not zero. A positive signal means more research is needed. Always discuss your personal situation with your doctor.
How do I find out if there’s a registry for my medication?
Ask your doctor or pharmacist. Many registries are run by hospitals or nonprofits like MotherToBaby. You can also search the FDA’s website or visit MotherToBaby.org, which lists active registries and how to enroll. If your drug is a newer biologic or psychiatric medication, there’s a good chance a registry exists.
Do I have to join a registry if I’m pregnant and taking medication?
No. Participation is completely voluntary. You’ll never be pressured to join. But if you do, your data helps future moms make safer choices. Many women find comfort in knowing they’re contributing to medical knowledge, even if they don’t get immediate answers.
Why do registries take so long to show results?
Because pregnancy and child development take time. Researchers need enough women to enroll, carry to term, and follow up for months or years to spot patterns. A single birth defect might happen in 1 in 1,000 babies. To detect a small increase, you need hundreds or thousands of cases. That takes years. Patience is part of the process.
Nicholas Heer
December 7, 2025 AT 16:46So let me get this straight - Big Pharma funds these ‘registries’? 😏 Of course they do. And you really think they’re not cherry-picking data to keep their billion-dollar drugs on the market? Thalidomide? That was 60 years ago. Now they just slap a registry on a drug like a Band-Aid on a bullet wound. FDA? More like FDA = For Sale Again. They’re all in bed together. You think your SSRI is ‘safe’? Try asking the kids with autism born to moms on Zoloft in 2012. Registry? More like PR stunt with a lab coat.
Stacy here
December 9, 2025 AT 15:32Y’all act like this is some noble science mission. Nah. This is corporate liability laundering. They don’t care if your baby’s fine - they care if the lawsuit gets buried. I’ve seen moms get told ‘your drug’s in a registry’ like it’s a magic shield. It’s not. It’s a delay tactic. And the ‘voluntary’ part? That’s just guilt-tripping anxious moms into becoming unpaid data miners. ‘Join and help future moms!’ Yeah, and when your kid has a seizure at 18 months? The registry won’t call you back for five years. Meanwhile, your insurance denied your therapy bills. Thanks, capitalism.
Kyle Flores
December 9, 2025 AT 20:49I get why people are skeptical, but I joined a registry when I was pregnant on lamotrigine. I was terrified. The coordinator called me every month. Asked about sleep, mood, even if I spilled coffee on my meds. I didn’t get instant answers, but I got updates. And honestly? Knowing I was part of something bigger - even if small - made me feel less alone. Not every registry is perfect, but some of us needed this. Not everyone’s out to scam you. Some of us just want our kids to be okay.
Ryan Sullivan
December 9, 2025 AT 22:05Registries are the medical equivalent of a PowerPoint slide titled ‘We Tried.’ The methodology is laughable - small sample sizes, selection bias, self-reported dosing. And you call this ‘evidence’? Real science requires controlled cohorts, blinding, statistical power. This is anecdotal noise dressed in epidemiology pajamas. If you want to know if a drug is safe, run a damn trial. Don’t beg anxious mothers to volunteer while the drug maker pockets $2B in annual revenue. This isn’t science. It’s PR theater with a consent form.
Wesley Phillips
December 11, 2025 AT 04:02Registries are cool and all but let’s be real - if your med’s got a registry, it’s probably because it’s either super new or super sketchy. Like, if your antidepressant has a registry, congrats - you’re basically a guinea pig for Big Pharma’s next quarterly report. I took sertraline while pregnant. No registry. No data. Just me, my anxiety, and Google. I’d rather know nothing than know ‘we’re collecting data.’ What’s that even mean? That my kid’s brain is a spreadsheet?
Nancy Carlsen
December 12, 2025 AT 05:54Just wanted to say thank you to the women who join these registries 🤍 You’re not just helping science - you’re helping moms like me who are terrified but don’t want to stop their meds. I joined the MotherToBaby registry for my ADHD med. I didn’t get quick answers, but I got a letter saying ‘no major risks found’ after my son turned 1. It meant the world. You’re not a lab rat. You’re a hero.
Helen Maples
December 13, 2025 AT 16:38Stop romanticizing registries. They’re underfunded, understaffed, and statistically useless for detecting rare outcomes. A registry with 120 participants cannot reliably detect a risk that occurs in 1 in 500 births. That’s basic math. And the ‘voluntary’ participation? That’s not empowerment - it’s exploitation of maternal guilt. If you want real safety data, mandate inclusion in clinical trials. Not after the fact. Not through volunteer moms. Right now.
Ashley Farmer
December 14, 2025 AT 12:02I know it’s hard to trust the system, but I’ve worked with these registries. The coordinators are nurses or pharmacists who care deeply. They’re not corporate bots. They call you on your birthday. They send cards after the baby’s born. They don’t get paid much. They do it because they’ve seen what happens when women stop meds and crash. This isn’t perfect - but it’s the best we’ve got. And it’s helping. Quietly. Slowly. But helping.
David Brooks
December 14, 2025 AT 17:04Let me tell you something - I was on lithium during pregnancy. Everyone told me to quit. I didn’t. I joined the registry. My son is now 7. No autism. No seizures. No developmental delays. He’s a ninja at chess. And I didn’t do it for science. I did it because I needed to know I wasn’t a monster. Registries don’t give guarantees - but they give hope. And sometimes? Hope is the only thing that keeps you from drowning.
Jennifer Anderson
December 15, 2025 AT 09:42my dr told me about the registry for my anxiety med and i was like ‘wait… i can join??’ i did. it felt weird at first - like i was being interviewed for a documentary. but then i got emails with updates and i realized… oh. i’m part of this. not just a patient. a contributor. my kid’s fine. and now other moms might not have to panic like i did. small thing. big deal.
Oliver Damon
December 17, 2025 AT 03:05The epistemological gap here is staggering. Registries operate under a post-hoc observational paradigm - inherently confounded by indication bias, recall error, and selection effects. The very notion that this constitutes ‘evidence’ is a category error. We conflate correlation with causation because we crave certainty. But data without control groups is not data - it’s narrative. The FDA’s reliance on these systems reflects institutional failure, not innovation. True progress demands prospective, randomized, inclusive trials - not volunteer-driven surveillance.
Kurt Russell
December 18, 2025 AT 13:26Listen. I was a single mom on anti-seizure meds. No husband. No family nearby. I was scared to death. Then I found MotherToBaby. They sent me a care package - a onesie, a journal, a phone number I could call anytime. I didn’t know if my baby would be okay. But I knew I wasn’t alone. Registries aren’t magic. But the people behind them? They’re angels in scrubs. If you’re pregnant and on meds - join. Not for science. For you. For the next mom who’s terrified too.
Olivia Hand
December 19, 2025 AT 12:25Why do registries only track birth defects? What about long-term neurodevelopment? ADHD? Anxiety? Learning delays? I’ve seen kids exposed to SSRIs in utero struggle in school at age 8 - but the registry stopped at 12 months. That’s not safety. That’s a checkbox. They’re measuring the wrong things. If we’re going to do this, do it right. Track kids until they’re 18. Otherwise, we’re just pretending we care.
Desmond Khoo
December 21, 2025 AT 01:28my wife joined a registry for her migraine med. they sent her a sticker. a real one. with a baby on it. she cried. not because it was science. but because someone remembered she was a person. not a data point. i don’t know if the registry mattered. but the fact that someone cared? that mattered more than any study.
Louis Llaine
December 21, 2025 AT 03:03So we spend $2 million a year to find out if a drug causes birth defects… but we won’t fund prenatal care for low-income moms? Brilliant. Let’s make the pregnant woman volunteer for a study while her Medicaid gets cut. Real public health. Real compassion. Real priorities. 🤡