Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Preterm Labor Drug: Nifedipine

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


Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Individualized Dosing of Nifedipine for Tocolysis in Preterm Labor
Study Start Date : July 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Plasma for determination of nifedipine and oxidized nifedipine concentrations Blood for DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090920


Locations
Layout table for location information
United States, Indiana
Eskenazi Health
Indianapolis, Indiana, United States, 46202
IU Health Methodist
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Sara Quinney, PharmD, PhD Indiana University Clinical Pharmacology

Layout table for additonal information
Responsible Party: Sara Quinney, Sara Quinney, Pharm D, PhD, Indiana University
ClinicalTrials.gov Identifier: NCT02090920     History of Changes
Other Study ID Numbers: 1106006106
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents