Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor

NCT02090920 | Completed DMC

• 1 other identifier: 1106006106
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

• prevention of delivery for 48 hours with attainment of uterine quiescence

  The primary study outcome is prevention of delivery for 48 hours with attainment of uterine quiescence, defined by 12 hours of six or fewer contractions per hour and no further cervical change. Failure of the primary outcome occurs if, in the first 48 hours, patients deliver, rupture membranes, experience recurrent preterm labor, continue to contract or experience cervical change, or required the use of alternate tocolytics. Secondary outcomes include time to uterine quiescence (≤6 contractions/hour), birth weight, gestational age at delivery, maternal and neonatal adverse effects.

  One Year

Study Arms (1)

Nifedipine

Nifedipine 10 mg immediate release tablet by mouth loading dose Nifedipine administered orally every 15-20 minutes for the first hour to a maximum loading dose of 30 mg, followed by a maintenance dose of 10-20 mg immediate release nifedipine administered orally every 6 hours

Drug: Nifedipine

Interventions

Nifedipine DRUG

Nifedipine 10 mg immediate release tablet by mouth loading dose Nifedipine administered orally every 15-20 minutes for the first hour to a maximum loading dose of 30 mg, followed by a maintenance dose of 10-20 mg immediate release nifedipine administered orally every 6 hours

Also known as: Adalat, Nifediac, Nifedical, Procardia, Procardia XL

Nifedipine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant Women with preterm labor who have been prescribed immediate release nifedipine and admitted at Eskenazi Health Hospital or Indiana University Methodist Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

IU Health Methodist

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma for determination of nifedipine and oxidized nifedipine concentrations Blood for DNA

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sara Quinney, PharmD, PhD

  Indiana University Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sara Quinney, Pharm D, PhD

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 18, 2014
• Study Start: July 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: April 1, 2019
• Last Updated: June 26, 2019

Record last verified: 2019-06

Locations

US (2)