Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. The study will also evaluate amlodipine concentrations in the infants of breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Center for Advancing Translational Science (NCATS)
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• 18 years or older;

• Pregnant female

• Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;

• Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery

• Breastfeeding or breast and bottle-feeding their infant

Exclusion Criteria:

• Known kidney disease

• Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage

• Administration of greater than 5 mg of amlodipine in 24 hour period