Status:
COMPLETED
Maternal Treatment With ACE-inhibitors and Breastfeeding: a Mono-centric Study on the Exposure Through Breast Milk
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
KU Leuven
Conditions:
Breast Feeding
Hypertension
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The ACE-inhibitors is one group of essential medication for which reliable data on the safety during breastfeeding is lacking. ACE inhibitors are indicated for several severe or life-threatening disor...
Eligibility Criteria
Inclusion
- For lactating mothers
- Lactating
- 0-6 months postpartum
- Age: ≥18 year
- On steady state ACE-inhibitor therapy, for any indication (e.g. perindopril, captopril, cilazapril, enalapril, fosinopril, lisinopril, quinapril, ramipril \& zofenopril)
- Willing to express breast milk
- Informed consent to participate and for processing their personal data
- For neonates/infants
- 0-6 months of age at inclusion of the mother
- Postmenstrual age: ≥ 37 weeks
- In case of blood sampling: exclusively breastfed at the time of sampling
- Parental informed consent to participate and for processing their personal data
Exclusion
- Participation in a trial with an investigational product within the previous three months
- Not meeting the inclusion criteria
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06088849
Start Date
December 20 2021
End Date
December 31 2023
Last Update
July 1 2024
Active Locations (1)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000