The Life-Saving Risk: What Parents Deserve to Know About Corticosteroids in Preterm Pregnancy

The Responsibility Clause - A medication that saves lives but is still used off-label raises an uncomfortable question—should parents be told everything?

Corticosteroid: A Lifesaving Standard

Few interventions in obstetrics have saved as many newborn lives as antenatal corticosteroids. Since the 1970s, they have been shown to accelerate fetal lung maturity and dramatically reduce respiratory distress, intraventricular hemorrhage, and neonatal death in preterm infants. ACOG, SMFM, and WHO all recommend corticosteroid administration when preterm birth is anticipated between 24 and 34 weeks, and possibly up to 36 weeks.

Corticosteroids were first introduced into obstetric practice in the 1970s, when studies showed they could accelerate fetal lung maturity and reduce neonatal death in preterm infants. At that time, many clinicians administered them weekly to women at ongoing risk for preterm birth, assuming that repeated dosing would maintain fetal benefit.

Over time, however, research revealed that multiple or closely spaced courses could impair fetal growth, reduce birthweight, and potentially affect neurodevelopment.

A 2007 study for example showed a slightly increased risk of cerebral palsy.

As evidence accumulated, professional guidelines changed—today, a single course is recommended, with a repeat course considered only in limited circumstances when preterm delivery remains imminent.

But what is less widely known is that this use remains off-label. No corticosteroid product is FDA-approved for accelerating fetal lung development. Despite decades of clinical evidence and global endorsement, the official labeling for drugs like betamethasone and dexamethasone does not include pregnancy or fetal benefit indications. Like misoprostol and nifedipine, corticosteroids belong to the small but critical group of medications that are standard in obstetrics yet unapproved for their most common purpose.

Does it matter?

The Other Side of Success

For most preterm pregnancies, corticosteroids are unquestionably beneficial. But that doesn’t mean they’re completely harmless. Recent studies have found potential adverse effects when corticosteroids are given in pregnancies that do not deliver preterm. A recent high-quality systematic review and meta-analysis in JAMA of more than 1.25 million children found that giving a single course of antenatal corticosteroids before very preterm birth clearly lowers the risk of serious neurodevelopmental impairment in those extremely preterm babies. But the same review also raised a safety signal: when corticosteroids were given in pregnancies that eventually delivered in the late preterm window or at term, exposure was associated with a higher adjusted risk of later neurocognitive, behavioral, or mental health disorders in those children.

The authors concluded: “Results of this study showed that exposure to a single course of antenatal corticosteroids was associated with a significantly lower risk of neurodevelopmental impairment in children with extremely preterm birth but a significantly higher risk of adverse neurocognitive and/or psychological outcomes in children with late-preterm and full-term birth, who made up approximately half of those with exposure to antenatal corticosteroids. The findings suggest a need for caution in administering antenatal corticosteroids.”

This doesn’t mean the drug should be withheld, it means its use requires precision. The benefits depend on the timing of birth, yet predicting preterm delivery remains one of obstetrics’ greatest uncertainties. When corticosteroids are given too early, repeated, or unnecessarily, the same drug that saves lives in one baby may alter brain development in another.

The authors of the JAMA study conclude: “Given that approximately 50% of children who had preterm exposure to antenatal corticosteroids exceeded expectations and were born full term, the timing and dose of antenatal corticosteroid administration should be carefully considered.”

The Ethical Line: Off-Label and Unspoken

Off-label use of proven medications is common in obstetrics, but ethical standards still apply. According to the AMA Code of Medical Ethics (Opinion 9.6.6), physicians must disclose when a treatment is off-label, describe the supporting evidence, discuss alternatives, and explain potential risks. Yet in practice, this conversation rarely happens. Most patients are told that corticosteroids “help the baby’s lungs,” not that the medication is unapproved for this use or that long-term developmental effects are still being studied.

This silence raises an ethical question: Is omission of such information withholding the truth? If a manufacturer explicitly limits a drug’s indication, and physicians routinely prescribe it for a different purpose without disclosure, patients are denied material facts that could influence their decision. Ethically, omission can be as misleading as misinformation.

What ACOG Says—And Doesn’t Say

ACOG’s 2024 Committee Opinion on Antenatal Corticosteroid Therapy for Fetal Maturation states that corticosteroids “should be administered when preterm birth is anticipated,” noting the substantial evidence of benefit. It does not, however, specify that corticosteroids remain unapproved for this indication. Nor does it recommend explicit informed consent beyond general counseling about benefits and risks.

By contrast, ACOG’s own definition of informed consent emphasizes that it is a “process of communication resulting in the patient’s authorization for a specific intervention,” requiring physicians to provide accurate, balanced information about the nature, risks, benefits, and alternatives of treatment before the procedure. If that standard applies to every obstetric intervention, it should also apply to off-label corticosteroid use.

Why Parents Should Know

Parents facing preterm birth are often terrified, overwhelmed, and desperate for reassurance. Most will choose corticosteroid treatment regardless, but choice is not the issue. Understanding is. When clinicians explain that corticosteroids are life-saving yet unapproved for this purpose, and that their safety depends on how early the baby is delivered, trust is strengthened, not weakened. Transparency signals respect. Concealment breeds doubt.

Parents should be told:

• Corticosteroids are off-label for fetal lung development.

• They save lives when true preterm birth is imminent.

• Repeated or unnecessary doses may affect long-term neurodevelopment.

• Timing and medical indication are critical to safety.

Honest, informed consent does not frighten parents, it honors them.

The Balance Between Benefit and Truth

The ethical tension here is not between saving lives and following rules. It is between beneficence and autonomy, between doing what we think is best and ensuring the patient fully understands what “best” really means. A physician’s duty is not only to treat but to tell the truth. When organizations and clinicians fail to disclose off-label status or manufacturer warnings, they risk substituting professional comfort for patient trust.

No guideline, however well intentioned, should justify silence.

Reflection / Closing

Corticosteroids remain one of medicine’s great success stories, but success does not erase responsibility. Every dose given off-label carries an ethical obligation to disclose that fact, to explain the balance of evidence and uncertainty, and to let patients decide with full understanding. Life-saving drugs deserve life-saving honesty.