Normal PregnancyDRUGS-PTPNCT04400084
Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta
An observational study of Normal Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Normal Pregnancy
- What is being tested?
- Placenta perfusion
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2020to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who give birth in the Port-Royal maternity (Paris)
Who may be able to join
- 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,
Who cannot join
- 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 :
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CIC Port-Royal-Cochin
Paris, 75014
Camille LE RAY, 00 33 1 58 41 38 17, camille.le-ray@aphp.fr
About this study
Official title: Ex Vivo Study of Drugs Transfer Across the Placenta
Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.
Read the detailed description
For ethical reasons, pregnant woman are not included in clinical trials so that data regarding safety and efficacy of many drugs are scarce. It is known that xenobiotics across the placental barrier but studies regarding quantity and mechanisms of this transfer remain insuffisant. Among the different methodologies to evaluate drug transfer, perfusion of human cotyledon is one of the most relevant ones. The two sides of the cotyledon, fetal and maternal ones, are perfused within the hour after delivery with EARLE medium in a double closed circuit. The studied drug (it can be any drug given to pregnant mothers) and antipyrine (the control molecule) are added at the beginning of the three hours perfusion realized at 37°C, with maternal flow rate of 12ml/min and fetal one of 6ml/min. Samples are collected along the perfusion and the drugs dosage will be done in the pharmacology department of Cochin Hospital. Tissues of the cotyledon will be also collected to study the proteins, and ARNs expressed. The drug concentrations will be analyzed by calculating fetal to maternal concentrations ratios and a fetal transfer rate (fetal drug quantity on total drug quantity at the end of the perfusion). Then modelling on Monolix software will be done to estimate the transfer constants across the two compartments. Modelling will allow to estimate the interindividual variability and to test covariables like sex, gestation duration, genetics, or protein expression. Proteins will be studied by an appropriated method (western blot, or proteomic analysis). The genetics study will consist in candidate gene approach. Polymorphisms will be chosen in genes coding for transporters or enzymes or their regulators.
- Conditions
- Normal Pregnancy
- Being tested
- Placenta perfusion
- Keywords
- Placenta, Drug, Transplacental transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placenta perfusionOther
Placenta perfusion in double closed circuit, during 3 hours
| Study group | Role | What they receive |
|---|---|---|
| Pregnant mothers | Pregnant mothers who have a normal pregnancy Receives: Other: Placenta perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal transfer rate
Quantity of drug transferred into fetal compartment/ quantity of drug in the two compartments *100
Measured: At 180 minutes (end of the perfusion)
Secondary outcomes (1)
Ratio of concentrations
Fetal concentration / maternal concentration *100
Measured: At 180 minutes (end of the perfusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start5 Jun 2020
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400084
- Sponsor's protocol ID
- APHP190817
- Acronym
- DRUGS-PTP
- Status last verified
- Sep 2025
- First submitted
- 19 May 2020
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider H, Panigel M, Dancis J. Transfer across the perfused human placenta of antipyrine, sodium and leucine. Am J Obstet Gynecol. 1972 Nov 15;114(6):822-8. doi: 10.1016/0002-9378(72)90909-x. No abstract available.
PubMed 4676572Hutson JR, Garcia-Bournissen F, Davis A, Koren G. The human placental perfusion model: a systematic review and development of a model to predict in vivo transfer of therapeutic drugs. Clin Pharmacol Ther. 2011 Jul;90(1):67-76. doi: 10.1038/clpt.2011.66. Epub 2011 May 11.
PubMed 21562489Preta LH, Bouazza N, Foissac F, Froelicher L, Urien S, Dauvilliers A, Dinnall A, Buth V, Benaboud S, Treluyer JM, Lui G. Comparison of human transplacental transfer of escitalopram, sertraline and paroxetine: an ex vivo cotyledon perfusion study. Placenta. 2025 Aug;168:150-158. doi: 10.1016/j.placenta.2025.06.015. Epub 2025 Jun 24.
PubMed 40580785
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Study of Drugs Transfer Across the Placenta
- ClinicalTrials.gov ID
- NCT04400084
- Acronym / sponsor ID
- DRUGS-PTP / APHP190817
- Conditions
- Normal Pregnancy
- Keywords
- Placenta, Drug, Transplacental transfer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.
Detailed description
For ethical reasons, pregnant woman are not included in clinical trials so that data regarding safety and efficacy of many drugs are scarce. It is known that xenobiotics across the placental barrier but studies regarding quantity and mechanisms of this transfer remain insuffisant. Among the different methodologies to evaluate drug transfer, perfusion of human cotyledon is one of the most relevant ones. The two sides of the cotyledon, fetal and maternal ones, are perfused within the hour after delivery with EARLE medium in a double closed circuit. The studied drug (it can be any drug given to pregnant mothers) and antipyrine (the control molecule) are added at the beginning of the three hours perfusion realized at 37°C, with maternal flow rate of 12ml/min and fetal one of 6ml/min. Samples are collected along the perfusion and the drugs dosage will be done in the pharmacology department of Cochin Hospital. Tissues of the cotyledon will be also collected to study the proteins, and ARNs expressed. The drug concentrations will be analyzed by calculating fetal to maternal concentrations ratios and a fetal transfer rate (fetal drug quantity on total drug quantity at the end of the perfusion). Then modelling on Monolix software will be done to estimate the transfer constants across the two compartments. Modelling will allow to estimate the interindividual variability and to test covariables like sex, gestation duration, genetics, or protein expression. Proteins will be studied by an appropriated method (western blot, or proteomic analysis). The genetics study will consist in candidate gene approach. Polymorphisms will be chosen in genes coding for transporters or enzymes or their regulators.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant mothers | – | Other: Placenta perfusionPregnant mothers who have a normal pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who give birth in the Port-Royal maternity (Paris)
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (13 listed)
- Maternal pathologies pre-existing pregnancy :
- Pregnancy and fetal pathologies :
- Patient under tutorship or curatorship, or not speaking french,
- Patient who has not given her consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placenta perfusionPlacenta perfusion in double closed circuit, during 3 hours | Other | Pregnant mothers |
Primary outcome
Fetal transfer rate
Time frame: At 180 minutes (end of the perfusion)
Quantity of drug transferred into fetal compartment/ quantity of drug in the two compartments *100
1 secondary outcome
Ratio of concentrations
Time frame: At 180 minutes (end of the perfusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 4676572Schneider H, Panigel M, Dancis J. Transfer across the perfused human placenta of antipyrine, sodium and leucine. Am J Obstet Gynecol. 1972 Nov 15;114(6):822-8. doi: 10.1016/0002-9378(72)90909-x. No abstract available.
- Background: PubMed 21562489Hutson JR, Garcia-Bournissen F, Davis A, Koren G. The human placental perfusion model: a systematic review and development of a model to predict in vivo transfer of therapeutic drugs. Clin Pharmacol Ther. 2011 Jul;90(1):67-76. doi: 10.1038/clpt.2011.66. Epub 2011 May 11.
- Results publication: PubMed 40580785Preta LH, Bouazza N, Foissac F, Froelicher L, Urien S, Dauvilliers A, Dinnall A, Buth V, Benaboud S, Treluyer JM, Lui G. Comparison of human transplacental transfer of escitalopram, sertraline and paroxetine: an ex vivo cotyledon perfusion study. Placenta. 2025 Aug;168:150-158. doi: 10.1016/j.placenta.2025.06.015. Epub 2025 Jun 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc TRELUYER, Pr (00 33 1 58 41 28 85, jean-marc.treluyer@parisdescartes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal transfer rate (time frame: At 180 minutes (end of the perfusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400084, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.