Pregnancy Registries: What We’re Learning About Medication Safety

Pregnancy Registries: What We’re Learning About Medication Safety

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When you’re pregnant and need to take a medication-whether it’s for depression, epilepsy, or an autoimmune condition-you’re not just thinking about yourself. You’re weighing every pill against the safety of your unborn child. But here’s the hard truth: pregnancy registries are the only real tool we have to answer that question with any kind of certainty. Clinical trials don’t include pregnant women. That’s ethical. But it leaves a massive gap in what we know. So who fills it? Pregnancy registries do. And what they’re learning is changing how doctors advise women every day.

Why Pregnancy Registries Exist

After the thalidomide disaster in the 1960s, where thousands of babies were born with severe limb deformities because their mothers took a then-approved sleeping pill, the medical world realized it couldn’t wait for tragedies to happen before acting. That’s when pregnancy registries began to take shape-not as a luxury, but as a necessity. Today, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require these registries for certain drugs, especially biologics and psychiatric medications, as a condition of approval.

These aren’t passive databases. They’re active, structured studies. When a woman takes a medication during pregnancy, she can enroll. Registry staff collect detailed info: exact drug name, dosage, timing of exposure, other meds she’s on, her medical history, lifestyle habits like smoking or alcohol use. Then they follow her through delivery and beyond-tracking whether the baby was born early, had a low birth weight, or developed a major birth defect. Some even track development up to 12 months after birth.

This is critical because pre-market trials exclude pregnant women. Even if a drug looks safe in 5,000 non-pregnant adults, we still won’t know how it affects a developing fetus until it’s used by thousands of pregnant women. Registries are the only way to get that data without putting women at risk in a trial.

What We’ve Learned So Far

Over 80 active pregnancy registries are running in the U.S. alone, and they’ve already shifted medical practice. For example, data from the National Pregnancy Registry for Psychiatric Medications showed that certain SSRIs like sertraline carry a much lower risk of major birth defects than previously feared. That’s led to fewer women being taken off their meds during pregnancy-reducing the risk of untreated depression, which itself can harm fetal development.

Antiepileptic drugs like lamotrigine have also been re-evaluated. Earlier studies suggested high risk, but registry data showed that with proper dosing, the risk of cleft lip or palate was only slightly above baseline. That’s huge for women with epilepsy who need to stay on medication to avoid seizures.

Even biologics-expensive, complex drugs used for conditions like rheumatoid arthritis or Crohn’s disease-are being studied. Registry data from drugs like adalimumab and certolizumab now show no clear pattern of birth defects, allowing many women to continue treatment through pregnancy without fear.

But it’s not all good news. Some drugs still carry red flags. For instance, isotretinoin (Accutane) for acne remains a known teratogen, and registries help enforce strict pregnancy prevention programs. Others, like valproic acid, are now clearly linked to cognitive delays and neural tube defects-so much so that guidelines now say it should be avoided entirely in pregnancy if possible.

How Registries Compare to Other Methods

You might wonder: Why not just use hospital records or insurance claims? Those exist, and they’re used too. But they’re messy. Electronic health records often don’t capture exact drug doses or timing. Insurance claims might show a prescription was filled, but not whether the woman actually took it. And they can’t tell you if a woman had morning sickness, stopped taking the drug, or took it only in the first trimester.

Pregnancy registries avoid these problems by collecting data prospectively-before outcomes are known. That means less recall bias. If a woman remembers taking a pill on day 28 of her cycle, that’s far more accurate than trying to guess it six months later.

But registries have limits. They’re small. Most enroll between 50 and 1,000 women. To detect a rare defect that occurs in 1 in 100 births, you’d need over 1,200 exposed pregnancies to be 80% confident you’d notice a doubled risk. That’s rarely reached. That’s why experts say registries don’t prove safety-they help rule out major risks.

Think of it like this: If you’re trying to find a needle in a haystack, a registry is a small, careful hand-search of a few bales. Database studies are a metal detector sweeping the whole field. Neither is perfect. Together, they’re stronger.

Woman taking medication during pregnancy, transitioning to holding healthy baby with safe drug icons.

Who Joins-and Why So Few Do

Enrollment is voluntary. And it’s hard. Only about 15-20% of eligible women who are offered participation actually sign up. Why? Time. Fear. Privacy concerns. Some worry their information could be shared with insurance companies or employers. Others feel overwhelmed already-doctor visits, ultrasounds, prenatal vitamins-and adding a registry feels like one more burden.

But those who do join often say it helps. MotherToBaby, which runs several registries, found that 78% of participants felt they made a meaningful contribution. Many appreciated getting personalized updates about the medication they were taking. One woman, taking lithium for bipolar disorder, told her registry counselor: “I didn’t want to be the one who didn’t know what was happening to my baby. I needed to know I wasn’t alone.”

Still, many women leave frustrated when they ask, “Is this safe?” and the registry staff can’t give a yes or no. That’s because registries are designed for long-term data collection, not instant answers. They’re not a hotline. They’re a research engine.

The Bigger Picture: Registries in a Changing System

The FDA launched the Pregnancy Safety Research Network in 2022 to link multiple registries together, standardize data, and increase statistical power. That’s a big step. Now, instead of 10 small studies, we’re starting to see pooled data from dozens. In 2024, the National Pregnancy Registry for Psychiatric Medications expanded to include 18 new drugs, bringing its total to 45. That’s the most comprehensive list of psychiatric meds studied in pregnancy anywhere in the world.

There’s also growing momentum to combine registry data with large health databases. Imagine a registry that automatically pulls in your lab results, ultrasound findings, and pediatric follow-ups from your electronic medical record. That’s the future-and it’s already being tested.

But challenges remain. Registries cost between $500,000 and $2 million a year to run. Many are funded by drug companies, which raises questions about bias-though all data is reviewed by independent scientists and published in peer-reviewed journals. And while 65% of new biologics approved between 2018 and 2022 required a registry, far fewer are required for older, generic drugs-even if they’re commonly used in pregnancy.

Global network of maternal health data nodes glowing in cosmic hospital skyline.

What This Means for You

If you’re pregnant and taking any medication-prescription, over-the-counter, or even supplements-talk to your provider about whether a registry is right for you. You might be eligible. You might not know it. And even if you’re not, the data from these registries is already helping your doctor make safer choices.

The bottom line: No drug is 100% proven safe in pregnancy. But registries are giving us the clearest picture we’ve ever had. They’re not perfect. They’re slow. They’re small. But they’re the only system we have that’s built specifically to protect the next generation.

What’s Next

The goal isn’t to replace registries. It’s to strengthen them. More integration with EHRs. Better outreach to underrepresented groups. Longer follow-up for neurodevelopmental outcomes. And most importantly-more women participating.

Because every woman who joins doesn’t just help herself. She helps the next woman who will face the same fear. And that’s how we turn uncertainty into evidence.

Are pregnancy registries safe to join?

Yes. Participation is completely voluntary and confidential. Registry staff are trained to protect your privacy, and your data is stored securely with identifiers removed. No insurance company, employer, or government agency can access your personal information through a registry. The only people who see your data are the research team and independent reviewers.

Can pregnancy registries tell me if a drug is safe for my baby right now?

No. Registries collect data over time to find patterns. They don’t give real-time safety advice. If you need immediate guidance, talk to your doctor or a specialist like a maternal-fetal medicine expert. Some registries partner with services like MotherToBaby, where you can call for up-to-date, evidence-based counseling-but that’s separate from the registry itself.

Do I have to be on a specific medication to join a registry?

Yes. Registries focus on specific drugs or drug classes-like antidepressants, antiseizure meds, or biologics for autoimmune diseases. You can’t just join any registry; you must be taking a medication that’s currently being studied. Your doctor or pharmacist can tell you if your medication is part of an active registry.

How long do I have to participate in a registry?

It varies. Most require you to complete follow-up until delivery, which is about 9-10 months. Some extend to 12 months postpartum to track developmental milestones. You can withdraw at any time, and your data will still be used unless you specifically ask for it to be removed.

What if I’m taking multiple medications during pregnancy?

That’s actually helpful. Registries track combinations of drugs, not just single medications. Many birth defects are linked to drug interactions or polypharmacy. By including women on multiple meds, registries give us a more realistic picture of how drugs behave in real life-where most people take more than one.

Are pregnancy registries only in the U.S.?

No. Similar programs exist in Europe, Canada, Australia, and other countries. The European Medicines Agency requires registries for certain drugs, and global efforts are increasing. Some registries are international, collecting data from multiple countries to improve statistical power. The World Health Organization supports these efforts as part of global pharmacovigilance.

Can I join a registry if I’m not sure whether the medication caused a birth defect?

Yes. Registries include women whose babies were born healthy and those with birth defects. Comparing outcomes across both groups is how researchers identify potential risks. Your participation-even if your baby is healthy-is just as valuable as someone whose baby had a complication.

Do pregnancy registries study vaccines too?

Yes. Vaccines like the flu shot, Tdap, and COVID-19 mRNA vaccines have been studied through pregnancy registries. Data from these studies helped confirm their safety during pregnancy and led to stronger recommendations from the CDC and WHO. Registries were critical in building public trust during the pandemic.

8 Comments

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    Erika Sta. Maria

    November 22, 2025 AT 10:13

    Okay but like… why are we still relying on VOLUNTARY registries in 2024? 😭 I mean, if we’re talking about protecting babies, why not just mandate participation? Like, you sign up for prenatal care, you’re automatically enrolled. No opt-out. No ‘I’m too overwhelmed.’ We’re not talking about a survey, we’re talking about FETAL SAFETY. And yet we treat it like a bake sale sign-up sheet. #FixThis

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    Steve Harris

    November 24, 2025 AT 08:58

    This is one of the most important public health topics no one talks about. The fact that we’ve been flying blind for decades with pregnant patients on meds is terrifying. Registries aren’t perfect, but they’re the only thing standing between a mother’s anxiety and actual data. Kudos to the teams running them - and to the women who participate. You’re literally saving future lives.

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    Michael Marrale

    November 24, 2025 AT 21:03

    Wait… so drug companies fund these registries? 🤔 Hmm. And you’re telling me they’re not manipulating the data? I’ve seen the reports - Big Pharma hides side effects for years. Remember Vioxx? Thalidomide was just the tip. What if they’re quietly cherry-picking healthy outcomes? What if they’re pressuring women to ‘forget’ the bad pregnancies? I’m not saying it’s happening… but I’m not saying it isn’t either. 🕵️‍♂️

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    David vaughan

    November 26, 2025 AT 16:53

    I joined the SSRIs registry when I was pregnant… and honestly? It helped me feel less alone. I was terrified. I kept thinking, ‘What if I’m the one who causes a defect?’ But the registry sent me monthly updates - real science, not fear-mongering. And when my baby was born healthy? I cried. Not because I was relieved… but because I knew I’d helped someone else down the line. 💙

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    David Cusack

    November 28, 2025 AT 13:19

    One must observe, with a certain degree of academic rigor, that the very notion of ‘pregnancy registries’ as a primary data source is fundamentally flawed - an epistemological stopgap, not a solution. One cannot extrapolate causality from observational, self-reported, low-n cohorts - especially when confounders such as socioeconomic status, maternal stress, and polypharmacy remain uncontrolled. The FDA’s reliance on such mechanisms is less ‘science’ and more… institutional inertia masquerading as precaution.

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    Elaina Cronin

    November 29, 2025 AT 12:17

    David Cusack is technically correct - but utterly tone-deaf. These registries are the only reason women like me can take lamotrigine without being told to ‘just quit’ and suffer seizures. You don’t get to sit in your ivory tower and dismiss the lived reality of thousands of women who are terrified, informed, and willing to participate. This isn’t about ‘epistemology.’ It’s about survival. And if you think this is ‘institutional inertia,’ then you’ve never held a newborn who almost didn’t make it because her mom stopped her meds.

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    Willie Doherty

    December 1, 2025 AT 02:41

    Let’s quantify this. The largest registry has 1,200 participants. The baseline risk of major birth defects is 3%. To detect a 1.5x increase with 80% power, you need 1,200. So… statistically, we’re barely scraping by. And yet we’re telling women ‘it’s safe.’ That’s not safety. That’s statistical luck. We need 10x the data. And we need mandatory reporting. Not voluntary. Not ‘if you feel like it.’

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    Darragh McNulty

    December 2, 2025 AT 10:36

    My wife joined the Tdap registry last year. She was nervous, but the team called her every trimester. Sent her a little card after the birth. 🤱❤️ We didn’t know we were helping science - but now we know. If you’re pregnant and on meds? Do it. It’s not a burden. It’s a legacy. And if you’re a doc? Push it. Like, actually push it. Not just ‘oh, we have a registry.’ But ‘here’s the link, let’s get you in.’

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