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Trial record 4 of 143 for:    NIFEDIPINE

Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor

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ClinicalTrials.gov Identifier: NCT02090920
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Quinney, Indiana University

Tracking Information
First Submitted Date March 3, 2014
First Posted Date March 18, 2014
Last Update Posted Date June 26, 2019
Study Start Date July 2011
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2014)
prevention of delivery for 48 hours with attainment of uterine quiescence [ Time Frame: One Year ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02090920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor
Official Title Individualized Dosing of Nifedipine for Tocolysis in Preterm Labor
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.
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

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma for determination of nifedipine and oxidized nifedipine concentrations Blood for DNA
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.
Condition Preterm Labor
Intervention Drug: 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
Other Name: Adalat, Nifediac, Nifedical, Procardia, Procardia XL
Study Groups/Cohorts 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
Intervention: Drug: Nifedipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 10, 2016)
20
Original Estimated Enrollment
 (submitted: March 17, 2014)
50
Actual Study Completion Date April 2019
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02090920
Other Study ID Numbers 1106006106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sara Quinney, Indiana University
Study Sponsor Indiana University
Collaborators Not Provided
Investigators
Principal Investigator: Sara Quinney, PharmD, PhD Indiana University Clinical Pharmacology
PRS Account Indiana University
Verification Date June 2019