Prenatal Tests and False Positives

Emily Oster

8 min Read Emily Oster

Emily Oster

Prenatal Tests and False Positives

Bayes’ rule is still very, very important

Emily Oster

8 min Read

Last week, the New York Times published a fantastic investigative piece on false positives in prenatal testing. One of the authors was the incomparable Sarah Kliff, and it is an absolutely awesome combination of on-the-ground reporting with patients, research into the companies that provide testing, and data visualization.

The conclusion of the piece was in some ways very alarming — these tests were not nearly as protective as they were sold to be.

Many people emailed me to ask about it, and the piece is so good that I wondered if there was really anything for me to add. But then I realized that there were no equations and no mention of Bayes’ rule. So I’m swooping in with more statistical lingo and to explain, just a bit more, why the conclusions shouldn’t have been surprising.

Background on prenatal testing 

Before getting into those equations, it’s worth stepping back to give a little background on the focus of the article, which is non-invasive prenatal testing.

When I was pregnant with Penelope, back in 2010, screening for chromosomal abnormalities (e.g. Down syndrome, other trisomies) came in two types. First, an ultrasound screening, which provided some information but with a lot of missed diagnoses. Second, invasive testing (either placental sampling earlier in pregnancy or amniocentesis later), which carried some risk of miscarriage but was more accurate.

By the time I was pregnant with Finn in 2014, a new option was available: non-invasive prenatal testing, using cell-free fetal DNA technology. These tests make use of the fact that some fetal DNA circulates in the maternal bloodstream. Treated correctly, a sample of blood from the pregnant person can be used to detect abnormalities in the fetus. To somewhat simplify, the approach is to look for evidence of DNA that wouldn’t otherwise be in the mother.

For example: let’s say you wanted to know the baby’s sex. The pregnant person typically has two X chromosomes. A male baby will have an XY, and a female will have XX. If you sample mom’s blood and you find evidence of circulating Y chromosomes in the cell-free DNA, this indicates a male fetus (since the mom’s own cell-free DNA wouldn’t contain a Y chromosome).

In their early conception, these tests were used to detect infant sex and the three primary trisomies (Down syndrome, trisomy 13, and trisomy 18). Detecting a trisomy means, effectively, looking for an imbalance in the presence of these chromosomes in the cell-free DNA. Assuming the pregnant person has two copies of each chromosome, if you observe an excess of chromosome 21 in the cell-free DNA, it suggests this must be due to an excess of chromosome 21 in the fetus, which would suggest Down syndrome.

These tests are very accurate for determining sex and Down syndrome in particular. Notably, they are substantially more accurate — both in terms of fewer false positives and false negatives — than the non-invasive ultrasound options that preceded them. However, they are still screening tests and not diagnostic. To be certain about these conditions, it is necessary to follow up a positive test with some invasive testing that is able to sequence fetal DNA.

The tests expanded

As a method for screening for major trisomies, there is some agreement about the value of these NIPT tests, as they are called. However, and this is the topic of the New York Times article, companies have started using these approaches to test for much, much rarer conditions. And therein lies the problem.

The conditions in question are mostly what are known as microdeletions. These are syndromes or disabilities that are a result of a small missing DNA piece in one chromosome. An example is the 22q11.2 deletion — a small missing piece of chromosome 22 that can lead to a developmental disorder called DiGeorge syndrome. This occurs in perhaps 1 in 4,000 births.

There are many kinds of these microdeletions, with varying prevalence, though all are quite rare. The claim, made frequently by NIPT-providing companies, is that the tests can detect microdeletions in the same way they detect Down syndrome or sex chromosomes. In a sense, they can. But in another sense, they are limited.

The Bayes’ analysis

To see the main issue, consider the test from a company called Harmony for this 22q11.2 microdeletion. Harmony provides some details about its test performance in this document.

According to the company’s analyses, the test detected 75% of cases with this deletion, and it saw only a 0.5% false positive rate. That is, of the cases without the microdeletion, only 0.5% of them showed a positive test result. As noted above, other sources put the overall risk of this microdeletion at about 1 in 4,000.

Let’s think about what that means if you do get a positive result.

To be concrete, imagine we have 80,000 people being tested. We expect, based on the underlying risk, that 20 of them are carrying a fetus with this microdeletion. When the 80,000 individuals are NIPT tested, 75% of those 20 cases (or 15, in expectation) will show up as positive tests. In addition, of the 79,980 people being tested who do not have a fetus with a microdeletion, 0.5% of them will get a false positive. That’s around 400 people.

Altogether, there are 415 positive tests: the 15 true positives, and 400 false positives. So if you get a positive test result, the chance that the fetus is actually affected is about 3.6%.

This is precisely the point that is made in the NYT story — that with these tests, which seem so accurate, in the vast majority of cases, even after a positive test, the fetus is in fact not affected.

The whole calculation is a straightforward application of Bayes’ rule, which I did a longer discussion of here. Intuitively, though, it somehow feels wrong. On its face, this sounds like a really good test! It detects 75% of cases, with only a 0.5% false positive rate. That seems like it should be helpful. And the fact is that it is really helpful, and it is hugely informative. Before the test, the risk was 1 in 4,000. After a positive test, it’s 4 in 100. This risk is a different order of magnitude — you’ve learned so much. You just haven’t learned everything.

The reason you can simultaneously have an excellent test and still this residual uncertainty is that the condition is very rare. This means that even a small false positive rate is a large number of false positive cases. The lower the baseline risk, the more significant this issue is.

Where’s the fire?

All of this is clear from an analysis of the published materials. If you read the find print and did the calculation, in principle the information was there. It’s not that the companies *lied* about their accuracy, at least not in terms of the numbers.

So what’s the issue driving the New York Times coverage? Primarily, it’s the companies overselling the accuracy of their tests, and the (completely understandable) patient reaction. In most cases, the literature from providers pays lip service to the idea that patients should undergo confirmative diagnostic testing before considering pregnancy termination or other measures. These confirmatory tests include either a CVS test or an amniocentesis; both are more invasive, so they aren’t likely to be the first step for many families, but they can provide certainty.

The companies say the need for this confirmation may be necessary. But in the same breath, the literature promotes the incredible accuracy of the tests.

The Times story uncovers cases of patients who underwent significant stress as a result of these false positive results, and even identifies cases in which patients terminated a pregnancy before confirmatory testing. That should not happen. Companies should not overstate the accuracy of their results. And doctors should be incredibly careful in how they present these tests and results to patients. Notably, I’d argue that it’s crucial to be clear with patients up-front about what they should expect with a positive result. Some of the biggest problems come when patients hear “positive” with little context; it can be difficult to grasp the nuances of false positives in a heightened emotional state.

From a patient standpoint, I think there is an important question about whether these tests are a good idea. On one hand, they do provide some information. On the other, the conditions they test for are very rare and in many cases somewhat poorly understood in terms of their impact. As a person who loves data, I err toward more information being better. But it’s only better if you understand and use it correctly.

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For children or adults with severe food allergies, they can be incredibly scary and restrictive. We may imagine that it’s easy to deal with a peanut allergy by, say, not eating peanut butter sandwiches. But for someone with a severe version of this allergy, they may never be able to go to a restaurant, for fear of a severe reaction to something in the air. Right now, there’s only one approved treatment for severe allergies like this and it’s limited to peanuts.

This is why the new medication Xolair is very exciting. It promises a second possible treatment avenue and one that works for other allergens. A new trail analyzed data from 177 children with severe food allergies. Two-thirds of the treatment group were able to tolerate the specified endpoint, versus just 7% of the placebo group. This is a very large treatment effect, and the authors found similarly large impacts on other allergens. 

There are some caveats: This treatment won’t work for everyone. (One-third of participants did not respond to it.) Additionally, this treatment is an injection given every two to four weeks, indefinitely. This may make it less palatable to children. 

Overall, even with caveats, this is life-changing news for many families!

#xolair #foodallergies #allergies #peanutallergy #emilyoster #parentdata

For children or adults with severe food allergies, they can be incredibly scary and restrictive. We may imagine that it’s easy to deal with a peanut allergy by, say, not eating peanut butter sandwiches. But for someone with a severe version of this allergy, they may never be able to go to a restaurant, for fear of a severe reaction to something in the air. Right now, there’s only one approved treatment for severe allergies like this and it’s limited to peanuts.

This is why the new medication Xolair is very exciting. It promises a second possible treatment avenue and one that works for other allergens. A new trail analyzed data from 177 children with severe food allergies. Two-thirds of the treatment group were able to tolerate the specified endpoint, versus just 7% of the placebo group. This is a very large treatment effect, and the authors found similarly large impacts on other allergens.

There are some caveats: This treatment won’t work for everyone. (One-third of participants did not respond to it.) Additionally, this treatment is an injection given every two to four weeks, indefinitely. This may make it less palatable to children.

Overall, even with caveats, this is life-changing news for many families!

#xolair #foodallergies #allergies #peanutallergy #emilyoster #parentdata
...

If you have a fever during pregnancy, you should take Tylenol, both because it will make you feel better and because of concerns about fever in pregnancy (although these are also overstated).

The evidence that suggests risks to Tylenol focuses largely on more extensive exposure — say, taking it for more than 28 days during pregnancy. There is no credible evidence, even correlational, to suggest that taking it occasionally for a fever or headache would be an issue.

People take Tylenol for a reason. For many people, the choice may be between debilitating weekly migraines and regular Tylenol usage. The impacts studies suggest are very small. In making this decision, we should weigh the real, known benefit against the suggestion of this possible risk. Perhaps not everyone will come out at the same place on this, but it is crucial we give people the tools to make the choice for themselves.

#emilyoster #parentdata #tylenol #pregnancy #pregnancytips

If you have a fever during pregnancy, you should take Tylenol, both because it will make you feel better and because of concerns about fever in pregnancy (although these are also overstated).

The evidence that suggests risks to Tylenol focuses largely on more extensive exposure — say, taking it for more than 28 days during pregnancy. There is no credible evidence, even correlational, to suggest that taking it occasionally for a fever or headache would be an issue.

People take Tylenol for a reason. For many people, the choice may be between debilitating weekly migraines and regular Tylenol usage. The impacts studies suggest are very small. In making this decision, we should weigh the real, known benefit against the suggestion of this possible risk. Perhaps not everyone will come out at the same place on this, but it is crucial we give people the tools to make the choice for themselves.

#emilyoster #parentdata #tylenol #pregnancy #pregnancytips
...

Parenting trends are like Cabbage Patch Kids: they’re usually only popular because a bunch of people are using them! Most of the time, these trends are not based on new scientific research, and even if they are, that new research doesn’t reflect all of what we’ve studied before.

In the future, before hopping onto the latest trend, check the data first. Unlike Cabbage Patch Kids, parenting trends can add a lot of unnecessary stress and challenges to your plate. What’s a recent trend that you’ve been wondering about?

#parentdata #emilyoster #parentingtips #parentingadvice #parentinghacks

Parenting trends are like Cabbage Patch Kids: they’re usually only popular because a bunch of people are using them! Most of the time, these trends are not based on new scientific research, and even if they are, that new research doesn’t reflect all of what we’ve studied before.

In the future, before hopping onto the latest trend, check the data first. Unlike Cabbage Patch Kids, parenting trends can add a lot of unnecessary stress and challenges to your plate. What’s a recent trend that you’ve been wondering about?

#parentdata #emilyoster #parentingtips #parentingadvice #parentinghacks
...

As of this week, 1 million copies of my books have been sold. This feels humbling and, frankly, unbelievable. I’m so thankful to those of you who’ve read and passed along your recommendations of the books.

When I wrote Expecting Better, I had no plan for all of this — I wrote that book because I felt compelled to write it, because it was the book I wanted to read. As I’ve come out with more books, and now ParentData, I am closer to seeing what I hope we can all create. That is: a world where everyone has access to reliable data, based on causal evidence, to make informed, confident decisions that work for their families.

I’m so grateful you’re all here as a part of this, and I want to thank you! If you’ve been waiting for the right moment to sign up for full access to ParentData, this is it. ⭐️ Comment “Link” for a DM with a discount code for 20% off of a new monthly or annual subscription to ParentData! 

Thank you again for being the best community of readers and internet-friends on the planet. I am so lucky to have you all here.

#parentdata #emilyoster #expectingbetter #cribsheet #familyfirm #parentingcommunity

As of this week, 1 million copies of my books have been sold. This feels humbling and, frankly, unbelievable. I’m so thankful to those of you who’ve read and passed along your recommendations of the books.

When I wrote Expecting Better, I had no plan for all of this — I wrote that book because I felt compelled to write it, because it was the book I wanted to read. As I’ve come out with more books, and now ParentData, I am closer to seeing what I hope we can all create. That is: a world where everyone has access to reliable data, based on causal evidence, to make informed, confident decisions that work for their families.

I’m so grateful you’re all here as a part of this, and I want to thank you! If you’ve been waiting for the right moment to sign up for full access to ParentData, this is it. ⭐️ Comment “Link” for a DM with a discount code for 20% off of a new monthly or annual subscription to ParentData!

Thank you again for being the best community of readers and internet-friends on the planet. I am so lucky to have you all here.

#parentdata #emilyoster #expectingbetter #cribsheet #familyfirm #parentingcommunity
...

Just eat your Cheerios and move on.

Just eat your Cheerios and move on. ...

The AAP’s guidelines recommend sleeping in the same room as your baby “ideally for the first six months.” However, the risk of SIDS is dramatically lower after four months, and the evidence in favor of the protective effect of room sharing is quite weak (both overall and even more so after four months). There is also growing evidence that infants who sleep in their own room by four months sleep better at four months, better at nine months, and even better at 30 months.

With this in mind, it’s worth asking why this recommendation continues at all — or at least why the AAP doesn’t push it back to four months. They say decreased arousals from sleep are linked to SIDS, which could mean that babies sleeping in their own room is risky. But this link is extremely indirect, and they do not show direct evidence to support it.

According to the data we have, parents should sleep in the same room as a baby for as long as it works for them! Sharing a room with a child may have negative impacts on both child and adult sleep. We should give families more help in navigating these trade-offs and making the decisions that work best for them.

#emilyoster #parentdata #roomsharing #sids #parentingguide

The AAP’s guidelines recommend sleeping in the same room as your baby “ideally for the first six months.” However, the risk of SIDS is dramatically lower after four months, and the evidence in favor of the protective effect of room sharing is quite weak (both overall and even more so after four months). There is also growing evidence that infants who sleep in their own room by four months sleep better at four months, better at nine months, and even better at 30 months.

With this in mind, it’s worth asking why this recommendation continues at all — or at least why the AAP doesn’t push it back to four months. They say decreased arousals from sleep are linked to SIDS, which could mean that babies sleeping in their own room is risky. But this link is extremely indirect, and they do not show direct evidence to support it.

According to the data we have, parents should sleep in the same room as a baby for as long as it works for them! Sharing a room with a child may have negative impacts on both child and adult sleep. We should give families more help in navigating these trade-offs and making the decisions that work best for them.

#emilyoster #parentdata #roomsharing #sids #parentingguide
...

It was an absolute pleasure to be featured on the @tamronhallshow! We talked about all things data-driven parenting and, in this clip, what I call the plague of secret parenting. To balance having a career and having a family, we can’t hide the fact that we’re parents. If mothers and fathers at the top can speak more openly about child-care obligations, it will help us all set a new precedent.

Watch the full segment at the link in my bio 🔗

#tamronhall #tamronhallshow #emilyoster #parentingsupport #workingparents

It was an absolute pleasure to be featured on the @tamronhallshow! We talked about all things data-driven parenting and, in this clip, what I call the plague of secret parenting. To balance having a career and having a family, we can’t hide the fact that we’re parents. If mothers and fathers at the top can speak more openly about child-care obligations, it will help us all set a new precedent.

Watch the full segment at the link in my bio 🔗

#tamronhall #tamronhallshow #emilyoster #parentingsupport #workingparents
...

Invisible labor. It’s the work — in our households especially — that has to happen but that no one sees. It’s making the doctor’s appointment, ensuring birthday cards are purchased, remembering the milk.

My guest on this episode, @everodsky, has come up with a solution here, or at least a way for us to recognize the problem and make our own solutions. I’ve wanted to speak with Eve for ages, since I read her book Fair Play. We had a great conversation about the division of household labor, one I think you’ll get a lot out of!

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#emilyoster #parentdata #parentdatapodcast #parentingpodcast #householdtips #fairplay #invisiblelabor

Invisible labor. It’s the work — in our households especially — that has to happen but that no one sees. It’s making the doctor’s appointment, ensuring birthday cards are purchased, remembering the milk.

My guest on this episode, @everodsky, has come up with a solution here, or at least a way for us to recognize the problem and make our own solutions. I’ve wanted to speak with Eve for ages, since I read her book Fair Play. We had a great conversation about the division of household labor, one I think you’ll get a lot out of!

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#emilyoster #parentdata #parentdatapodcast #parentingpodcast #householdtips #fairplay #invisiblelabor
...

Prenatal vitamins 💊 If there is any product that seems designed to prey on our fears, it’s this one. You’re newly pregnant and you want to do it right. Everyone agrees you need prenatal vitamins, so you get them. But do you want to be that person who just… buys the generic prenatal vitamins?

Good news: fancier vitamins are not better.  Folic acid is the most important prenatal ingredient. Iron (with vitamin C) and DHA are also nice to have. Other included ingredients have only weak or no evidence to support their use. (If you do not consume animal products, add B12, plus a few others depending on your diet.)

Vitamins are just vitamins. Any prenatal vitamin that contains these is enough. 

Comment “Link” for a DM to an article with everything you need to know about prenatal vitamins.

#emilyoster #parentdata #prenatalvitamins #pregnancydiet #pregnancytips

Prenatal vitamins 💊 If there is any product that seems designed to prey on our fears, it’s this one. You’re newly pregnant and you want to do it right. Everyone agrees you need prenatal vitamins, so you get them. But do you want to be that person who just… buys the generic prenatal vitamins?

Good news: fancier vitamins are not better. Folic acid is the most important prenatal ingredient. Iron (with vitamin C) and DHA are also nice to have. Other included ingredients have only weak or no evidence to support their use. (If you do not consume animal products, add B12, plus a few others depending on your diet.)

Vitamins are just vitamins. Any prenatal vitamin that contains these is enough.

Comment “Link” for a DM to an article with everything you need to know about prenatal vitamins.

#emilyoster #parentdata #prenatalvitamins #pregnancydiet #pregnancytips
...

When it comes to introducing your newborn to the world, timing matters. It’s a good idea to minimize germ exposure in the first 6-8 weeks; after that, it’s inevitable and, very likely, a good idea! This doesn’t mean you need to be trapped inside. The most significant exposure risks are from seeing other people at home — family, etc. These interactions are not infinitely risky, but they do pose more risk than a walk or a trip to the grocery store, since they involve closer interaction. Think simple and make sure everyone is washing their hands before holding the baby. 💛

#parentdata #emilyoster #newborncare #parentingadvice #parentingtips

When it comes to introducing your newborn to the world, timing matters. It’s a good idea to minimize germ exposure in the first 6-8 weeks; after that, it’s inevitable and, very likely, a good idea! This doesn’t mean you need to be trapped inside. The most significant exposure risks are from seeing other people at home — family, etc. These interactions are not infinitely risky, but they do pose more risk than a walk or a trip to the grocery store, since they involve closer interaction. Think simple and make sure everyone is washing their hands before holding the baby. 💛

#parentdata #emilyoster #newborncare #parentingadvice #parentingtips
...

The first edition of Hot Flash is out now! Comment “Link” for a DM to learn more about the late-reproductive stage.

There are times when we expect hormonal shifts. Our reproductive lives are bookended by puberty and menopause. We discuss those changes often because they are definitive and dramatic — a first period is something many of us remember clearly. But between ages 13 and 53, our hormones are changing in more subtle ways. During the late-reproductive stage (in your 40s), you can expect a lot of changes in your menstrual cycle, including the length and symptoms you experience throughout. It’s an important time in our lives that is often overlooked!

🔥 Hot Flash from ParentData is a weekly newsletter on navigating your health and hormones in the post-reproductive years. Written by Dr. Gillian Goddard, Hot Flash provides all of the information you need to have a productive, evidence-based conversation about hormonal health with your doctor.

#emilyoster #parentdata #hotflash #perimenopause #womenshealth

The first edition of Hot Flash is out now! Comment “Link” for a DM to learn more about the late-reproductive stage.

There are times when we expect hormonal shifts. Our reproductive lives are bookended by puberty and menopause. We discuss those changes often because they are definitive and dramatic — a first period is something many of us remember clearly. But between ages 13 and 53, our hormones are changing in more subtle ways. During the late-reproductive stage (in your 40s), you can expect a lot of changes in your menstrual cycle, including the length and symptoms you experience throughout. It’s an important time in our lives that is often overlooked!

🔥 Hot Flash from ParentData is a weekly newsletter on navigating your health and hormones in the post-reproductive years. Written by Dr. Gillian Goddard, Hot Flash provides all of the information you need to have a productive, evidence-based conversation about hormonal health with your doctor.

#emilyoster #parentdata #hotflash #perimenopause #womenshealth
...

There are plenty of reels telling you how to parent. Plenty of panic headlines saying that “studies show” what’s best for your kid. Even good data, from a trusted source, can send us into a spiral of comparison. But I want you to remember that no one knows your kid better than you. It’s important to absorb the research, but only you will know the approach that works best for you and your child. 💙

Now tell me in the comments: what’s a parenting move you’ve made recently that feels right to you?

#parentingcommunity #parentingsupport #parentingquotes #emilyoster #parentdata

There are plenty of reels telling you how to parent. Plenty of panic headlines saying that “studies show” what’s best for your kid. Even good data, from a trusted source, can send us into a spiral of comparison. But I want you to remember that no one knows your kid better than you. It’s important to absorb the research, but only you will know the approach that works best for you and your child. 💙

Now tell me in the comments: what’s a parenting move you’ve made recently that feels right to you?

#parentingcommunity #parentingsupport #parentingquotes #emilyoster #parentdata
...

Let’s talk about sex (after) baby! Today on the podcast, I was lucky enough to speak with @enagoski about her new book on sexual connection in long-term relationships. Especially after having kids, this is something many people struggle with. Emily tells us to stop worrying about what’s “normal” and focus on pleasure in its many forms.

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#parentdata #parentdatapodcast #emilyoster #emilynagoski #comeasyouare #cometogether #longtermrelationship #intimacy #relationships

Let’s talk about sex (after) baby! Today on the podcast, I was lucky enough to speak with @enagoski about her new book on sexual connection in long-term relationships. Especially after having kids, this is something many people struggle with. Emily tells us to stop worrying about what’s “normal” and focus on pleasure in its many forms.

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#parentdata #parentdatapodcast #emilyoster #emilynagoski #comeasyouare #cometogether #longtermrelationship #intimacy #relationships
...

Ever wondered if you can safely use leftover baby formula? 🍼 The CDC says to throw out unused formula immediately because of the risk of bacterial growth. However, research suggests that bacterial concentrations do not appreciably increase after 3, 12, or even 24 hours at refrigerator temperatures. Good news! This means there’s not a strong data-based reason to throw out formula right away if you store it in the fridge.

Comment “Link” for a DM to an article on another common formula question: should you throw away old formula powder?

#emilyoster #parentdata #babyformula #babyfeeding #parentingstruggles

Ever wondered if you can safely use leftover baby formula? 🍼 The CDC says to throw out unused formula immediately because of the risk of bacterial growth. However, research suggests that bacterial concentrations do not appreciably increase after 3, 12, or even 24 hours at refrigerator temperatures. Good news! This means there’s not a strong data-based reason to throw out formula right away if you store it in the fridge.

Comment “Link” for a DM to an article on another common formula question: should you throw away old formula powder?

#emilyoster #parentdata #babyformula #babyfeeding #parentingstruggles
...

What’s the most important piece of advice for new parents? Here’s one answer, but I want to hear from you! Share your suggestions in the comments ⬇️

#emilyoster #parentdata #parentingtips #parentingadvice #newparents #parentingcommunity

What’s the most important piece of advice for new parents? Here’s one answer, but I want to hear from you! Share your suggestions in the comments ⬇️

#emilyoster #parentdata #parentingtips #parentingadvice #newparents #parentingcommunity
...

What's in the bag of a Vagina Economist? 👀 Someone please tell me this looks familiar to you.

What`s in the bag of a Vagina Economist? 👀 Someone please tell me this looks familiar to you. ...