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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 September 2022
Main ID:	NCT02438631
Date of registration:	06/05/2015
Prospective Registration:	No
Primary sponsor:	Radboud University Medical Center
Public title:	Placental Passage and Disposition of Drugs: A Physiology-based Approach PIANO
Scientific title:	Placental Passage and Disposition of Drugs: A Physiology-based Approach
Date of first enrolment:	February 2015
Target sample size:	2000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02438631
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Netherlands

Contacts

Name:	J van Drongelen
Address:
Telephone:
Email:	joris.vandrongelen@Radboudumc.nl
Affiliation:

Name:	J van Drongelen
Address:
Telephone:
Email:
Affiliation:	Radboud University Medical Center

Name:	Joris M van Drongelen, MD PhD
Address:
Telephone:
Email:	joris.vandrongelen@Radboudumc.nl
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female

- Age > 18

- Signed informed consent

- >38 weeks pregnant

Exclusion Criteria:

- Retained placenta

- HIV infected

- Known hepatitis C infection

- Multiple pregnancy

- Congenital birth defects child

- Sectio EXIT procedure

Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy

Intervention(s)

Primary Outcome(s)

placental transfer [Time Frame: at delivery]

histological profiling [Time Frame: at delivery]

in vitro experiments [Time Frame: at delivery]

Secondary Outcome(s)

Secondary ID(s)

PIANO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme LLC

PENTA Foundation

Top sector Life Sciences & Health

Janssen Pharmaceuticals

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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