Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor
Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Labor
Intervention: Nifedipine (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s): Sara Quinney, PharmD, PhD, Principal Investigator, Affiliation: Indiana University Clinical Pharmacology
Summary
This study looks at the effects of a mother's genes and other characteristics (mother's age,
baby's age, race, and other diseases) on the ability of nifedipine to end contractions and
prevent an early delivery. This information will be used to decide what amount of
nifedipine women need to best treat preterm contractions.
Clinical Details
Official title: Individualized Dosing of Nifedipine for Tocolysis in Preterm Labor
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: prevention of delivery for 48 hours with attainment of uterine quiescence
Detailed description:
The purpose of this study is to identify the relationship between the amount of nifedipine
in a woman's body and its effect on ending preterm (early) labor contractions and delaying
delivery by at least 48 hours. The study will also look at the effects of genes (materials
passed from parent to child that determine the make-up of the body) and other
characteristics (for example mother's age, baby's age, race, and other diseases or drugs) on
the ability of nifedipine to end the contractions. We will use this information to decide
what amount of nifedipine women need to best treat preterm contractions. This study will
also examine the effect of pregnancy on how fast nifedipine is removed from the woman's
body.
This study will be conducted on two phases. The first will study women who are starting
nifedipine for treatment of preterm labor. Nifedipine dose will be determined by the
patient's physician. Blood samples will be obtained from the mother to determine the
concentration of nifedipine and its metabolite, oxidized nifedipine, during one dosing
interval. A blood sample will also be obtained for DNA isolation to examine variants in
genes involved in the nifedipine pathway. We will also collect data on uterine contractions
and blood pressure through clinical monitoring. After delivery, maternal and umbilical cord
blood samples will be obtained, along with a piece of placenta. Women who take part in the
first phase will be asked to return 6-10 weeks after delivery. At that time, she will take
a single dose of 10 mg immediate release nifedipine by mouth and blood samples will be
collected for up to 6 hours. Blood pressure will also be monitored prior to collection of
each blood sample
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Pregnant women 18 years of age or older
- Diagnosed with preterm labor (defined as 1-3 uterine contractions per 10
minute interval for at least 60 minutes with evidence of change in cervical dilation
and/or effacement)
- Prescribed nifedipine as a tocolytic agent
- Signed informed consent
Exclusion Criteria:
- Multifetal gestation
- Cervical dilation of 5 cm or greater
- Ruptured uterine membranes
- Any medical or obstetrical condition that would contraindicate tocolytic therapy
including placental abruption; placenta previa; nonreassuring fetal status; uterine
growth restriction; severe congenital abnormalities
- Administration of medications known to interact with CYP3A (a human gene) other than
betamethasone or dexamethasone as indicated for stimulating fetal lung maturation,
within the past 24 hours unless approved by study investigators
- Administered a potent mechanism-based CYP3A inhibitor (e. g. erythromycin,
clarithromycin) in past 48 hours
- History of allergy or hypersensitivity to nifedipine
- History of taking grapefruit or grapefruit juice by mouth within the last 24 hours
- Known current hepatic or renal disease
Locations and Contacts
Eskenazi Health, Indianapolis, Indiana 46202, United States; Recruiting Cindy Evrard, BSN, RN, Phone: 317-880-3953, Email: caevrard@iu.edu Sara Quinney, PharmD, PhD, Phone: 317-274-2796, Email: squinney@iupui.edu
IU Health Methodist, Indianapolis, Indiana 46202, United States; Recruiting Cindy Evrard, BSN, RN, Phone: 317-880-3953, Email: caevrard@iu.edu Sara Quinney, PharmD, PhD, Phone: 317-274-2796
Additional Information
Starting date: July 2011
Last updated: August 20, 2015
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