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Pooled pregnancy data showed no malformation increase, at low certainty

Seven cohort studies, more than 40,000 exposed pregnancies. Every main outcome is null, and the one positive finding has no adjustment behind it.

Dana Sullivan6 min read
Odds ratios after exposure in pregnancy1.0any malformationmajor, 1st trimesterurinary (unadjusted)Two cross 1.0. The third has no adjustment behind it.

Start with what this article is not. These drugs are not approved for use in pregnancy, and nothing below is a reason to take one while pregnant or trying to conceive. This is observational data about pregnancies that were exposed, frequently before anyone knew about them, and the question it answers is what happened to those pregnancies [1]. The contraception interaction that puts people in that position is covered in what tirzepatide does to oral contraception.

Across seven cohort studies and more than 40,000 exposed pregnancies, exposure at any point was not associated with congenital malformations overall, at an odds ratio of 1.11 with an interval from 0.82 to 1.51. First-trimester exposure and major malformations came in at 1.39, with an interval from 0.73 to 2.65. Stillbirth, spontaneous abortion, small for gestational age and preterm birth all showed no significant increase.

One outcome did clear statistical significance. Urinary malformations came in at an odds ratio of 1.24 with an interval from 1.05 to 1.47 — and that estimate rests exclusively on unadjusted data. The authors say so themselves and read it as likely residual confounding rather than a real effect, which is a stronger caveat than most papers attach to their own positive finding. The unadjusted-estimate problem is the same one this site described in the trial whose one positive was unadjusted.

Residual confounding is a live concern here specifically because of who gets exposed. People taking these drugs into a pregnancy have higher baseline BMI, more diabetes and more cardiometabolic disease than the general obstetric population, and all of those independently affect pregnancy outcomes. Separating drug from indication in observational data is the problem this site set out in what happens when the control group never started treatment.

The practical reading is narrow and worth having. If a pregnancy was exposed before it was known about, the pooled evidence so far does not show an increase in the outcomes that question usually concerns. That is a different statement from the drug being safe in pregnancy, which nobody has established and no trial is likely to test.

Frequently asked

Is it safe to take a GLP-1 drug while pregnant?
That is not what this evidence establishes. These drugs are not approved in pregnancy, the pooled certainty of evidence is graded low, and the authors describe their findings as cautiously reassuring rather than reassuring.
What did the analysis find?
No significant association with any congenital malformation (OR 1.11, 95% CI 0.82 to 1.51), major malformations after first-trimester exposure (OR 1.39, 95% CI 0.73 to 2.65), stillbirth, spontaneous abortion, small for gestational age or preterm birth.
What about the urinary malformation finding?
It reached significance at OR 1.24 (95% CI 1.05 to 1.47) but rests entirely on unadjusted estimates. The authors attribute it to likely residual confounding.

Sources

  1. [1] Uysal N, Horoz E, Gungor M, Timarci I, Sozmen MK, Karadas B (2026). Pregnancy outcomes following maternal GLP-1 receptor agonist exposure: a systematic review and meta-analysis Scientific Reports. PMID 42420519

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