Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor

June 25, 2019 updated by: Sara Quinney, Indiana University

Individualized Dosing of Nifedipine for Tocolysis in Preterm Labor

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Health
      • Indianapolis, Indiana, United States, 46202
        • IU Health Methodist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Adalat, Nifediac, Nifedical, Procardia, Procardia XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Sara Quinney, PharmD, PhD, Indiana University Clinical Pharmacology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1106006106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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