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Are IBD drugs safe in pregnancy? large french study investigates

NCT ID NCT03134508

Knowledge-focused Sponsor: Centre Hospitalier Universitaire Dijon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study analyzed data from over 8,700 pregnant women with inflammatory bowel disease (Crohn's or ulcerative colitis) to see how well doctors follow guidelines when prescribing antiTNFα drugs and whether the benefits outweigh the risks for both mother and baby. Researchers looked at complications related to the disease, treatment, and pregnancy, as well as infections in babies during their first year. The goal is to provide clearer evidence for safer treatment decisions during pregnancy.

What this could mean

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

Active substance
antiTNFα (anti-tumor necrosis factor alpha) drugs
What this could lead to
If successful, this could help doctors make safer decisions about using antiTNFα drugs during pregnancy in women with inflammatory bowel disease.
What could go wrong
This is an observational study using existing hospital records, not a controlled trial. It can show associations but cannot prove cause and effect. Results may not apply to other countries or populations.

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

Study facts

What this study's own registry entry says, in plain language.

Participants

8,726 people

The number who actually took part.

Started

Mar 2016

Finished

Apr 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All pregnant women with a diagnosis of IBD

Ages

15 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * pregnancy between 01/01/2011 and 31/12/2014 * Diagnosis of IBD (Crohn's disease or Ulcerative Colitis) Exclusion Criteria: * Non IBD indication of antiTNFα treatment

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflammatory bowel diseases

Contacts and locations

Locations

  • Chu de Dijon

    Dijon, France

More trials for these conditions

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