Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Nifedipine

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