Overview

Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.

Status:
Unknown status
Trial end date:
2019-10-01
Target enrollment:
0
Participant gender:
Female
Summary
This study aims to investigate the influence of the c.421C>A genetic polymorphism of the ABCG2 / BCRP transporter in the concentration ratio of nifedipine in maternal milk:plasma in hypertensive breastfeeding women attended at the Gynecology and Obstetrics Service of the Medical School of Ribeirão Preto, of the University of São Paulo. Thus, plasma and breast milk samples are being collected from patients in chronic use of the drug (n=30) within 15 to 30 days postnatal.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Natalia Valadares de Moraes
Collaborator:
Hospital das Clínicas de Ribeirão Preto
Treatments:
Nifedipine
Criteria
Inclusion Criteria:

- Chronic hypertensive breastfeeding women

- Patients being treated with 20 mg slow-release nifedipine every 12 hours for at least
15 days

Exclusion Criteria:

- Patients in use of ABCG2 inhibitors (omeprazole, pantoprazole, ritonavir, saquinavir,
imatinib, efavirenz, nicardipine, abacavir, tacrolimus, ciclosporin A, cannabidiol);

- Patients who presented nifedipine adverse drug reactions

- Patients whose blood pressure normalized after delivery

- Patients who interrupted breastfeeding during the study

- Patients who did not return to the hospital for the clinical protocol.