Placenta study aims to unlock drug safety in pregnancy

NCT ID NCT04400084

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study uses placentas donated after childbirth to measure how drugs pass from mother to fetus. Researchers will perfuse the placenta in a lab to calculate drug transfer rates. The goal is to fill a gap in knowledge about medication safety during pregnancy, since pregnant women are often excluded from drug trials. Up to 2,000 women with normal pregnancies will participate.

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 successful, this could help doctors understand which drugs are safe during pregnancy and how they affect the fetus.
What could go wrong: This is an ex vivo lab study using placentas after birth, not a treatment trial. Results may not fully predict real-life drug effects in pregnant women.

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

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Jun 2030

An estimate. End dates often move.

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

Pregnant women who give birth in the Port-Royal maternity (Paris)

Ages

18 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: * pregnant women older than 18 years, * patient with social security or health insurance, * from the 24th week of amenorrhea, * patient who has given her consent, Exclusion Criteria: * Maternal pathologies pre-existing pregnancy : * diabetes-like vascular disease, * arterial hypertension, * known prothrombotic pathology, history of venous thrombosis or pulmonary embolism, * maternal serology HIV+, BHV+, CHV+ and syphilis, * Pregnancy and fetal pathologies : * pre-eclampsia, * delayed growth in utero (can affect placental circulation), * gestational diabetes without insulin, * fetal malformation, * known genetic pathology, * Patient under tutorship or curatorship, or not speaking french, * Patient who has not given her consent

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As listed by the trial registrant

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

Normal pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Placenta study aims to unlock drug safety in pregnancy

What the study statuses mean