Is this constipation pill safe for pregnant women? new study investigates

NCT ID NCT04961840

Ongoing Knowledge-focused Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study uses insurance claims data to see if taking the constipation drug prucalopride during pregnancy is linked to birth defects or other problems for mothers and babies. Researchers will compare pregnant women who took prucalopride, those who took other constipation medicines, and those who took none. The goal is to gather safety information, but because it only looks at past records, it cannot prove whether the drug causes any issues.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

What this could lead to: If the study finds no increased risks, it could provide reassurance that prucalopride is safe to use during pregnancy.
What could go wrong: This is an observational study using existing data, not a controlled trial, so it cannot prove cause and effect. Results may be limited by the accuracy of insurance records.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

constipation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CONSTIPATION PREGNANCY

Contacts and locations

Locations

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.