NCT04400084

Brief 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 functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2020Jun 2030

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

June 5, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

May 19, 2020

Last Update Submit

September 5, 2025

Conditions

Normal Pregnancy

Keywords

PlacentaDrugTransplacental transfer

Outcome Measures

Primary Outcomes (1)

  • Fetal transfer rate

    Quantity of drug transferred into fetal compartment/ quantity of drug in the two compartments \*100

    At 180 minutes (end of the perfusion)

Secondary Outcomes (1)

  • Ratio of concentrations

    At 180 minutes (end of the perfusion)

Study Arms (1)

Pregnant mothers

Pregnant mothers who have a normal pregnancy

Other: Placenta perfusion

Interventions

Placenta perfusionOTHER

Placenta perfusion in double closed circuit, during 3 hours

Pregnant mothers

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC Port-Royal-Cochin

Paris, 75014, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 4676572BACKGROUND

  • Hutson 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.

    PMID: 21562489BACKGROUND

  • Preta 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.

    PMID: 40580785BACKGROUND

Central Study Contacts

Jean-Marc TRELUYER, Pr

CONTACT

00 33 1 58 41 28 85jean-marc.treluyer@parisdescartes.fr

Marie BENHAMMANI-GODARD

CONTACT

00 33 1 54 41 12 11marie.godard@aphp.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

June 5, 2020

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)