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Nifedipine Pharmacokinetics and Pharmacodynamics When Used as a Tocolytic in Acute Threatened Preterm Labour

Information source: Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Labor

Intervention: Nifedipine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Chantal Csajka

Official(s) and/or principal investigator(s):
Alice Panchaud, PhD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire Vaudois

Overall contact:
Alice Panchaud, PhD, Phone: 0213144276, Ext: +41, Email: Alice.Panchaud@chuv.ch


Preterm birth is the leading cause of perinatal mortality and morbidity. According to WHO, 15 million children are born prematurely (gestational age < 37 weeks) in the world each year while 7% of them die because of complications associated with prematurity. Despite constant improvement of obstetrical care, the number of preterm births has increased over the last decades and prematurity is still the most frequent cause of prenatal hospitalization in industrialized countries. The American College of Obstetricians and Gynecologists as well as the Royal College of Obstetricians and Gynaecologists recommend nifedipine as a first-line tocolytic in case of acute threatened preterm labour. Clinical experience show however an important variability in treatment response among pregnant women. In spite of its large use in obstetrics as a tocolytic agent, nifedipine is prescribed off-label. As a consequence no international consensus on optimal dose schedule has so far been proposed. Small sample size and heterogeneousness of tocolysis administration protocols make it difficult to compare the little data available on the pharmacokinetics of nifedipine in pregnant women. Nevertheless an important interindividual variability in concentrations has been identified (CV=12-76%) but very few studies have investigated the possible reasons of this variability in pregnant women. Genetic and environmental factors involved in drug distribution and metabolism (e. g. enzymatic activity, CYP 3A5 genotype) might partially explain variability in drug levels and therefore differences in treatment response. The goal of this study is to quantify the variability in nifedipine pharmacokinetics and identify potential genetic and non-genetic sources of variability in nifedipine pharmacokinetics in pregnant women. The relationship between concentration and treatment response will be evaluated and will serve to propose optimal dosage regimen to improve efficacy and reduce side effects associated with this treatment.

Clinical Details

Official title: Nifedipine Pharmacokinetics and Pharmacodynamics When Used as a Tocolytic in Patients Hospitalized for Acute Threatened Preterm Labour

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Nifedipine blood concentration



Secondary outcome:

Nifedipine side effects (feeling)

Maternal heart rate (measurement)

Maternal blood pressure (measurement)

Fetal heart rate (measurement)

Uterine contraction (measurement)

Uterine contraction (feeling)

Birth date


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Pregnant women under nifedipine treatment for acute threatened preterm labour

- Hospitalization for this condition in the maternity of the University Hospital of

Lausanne (CHUV)

- Gestational age of 20-34 weeks

- Signed informed consent

Exclusion Criteria:

- Patient < 18 years

- Contraindication to tocolysis for clinical reasons (e. g. severe pre-eclampsia,

chorioamnionitis, placental anomaly, letal fetal anomaly, important intrauterine growth restriction) or current labour

- Contraindication to nifedipine

- Severe renal or hepatic impairment

- Fever > 37. 5°C

- Incapacity of communication

Locations and Contacts

Alice Panchaud, PhD, Phone: 0213144276, Ext: +41, Email: Alice.Panchaud@chuv.ch

Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud 1011, Switzerland; Recruiting
Alice Panchaud, PhD, Phone: 0213144276, Ext: +41, Email: Alice.Panchaud@chuv.ch
Alice Panchaud, PhD, Principal Investigator
David Baud, MD PhD MER, Sub-Investigator
Chantal Csajka, Prof PhD, Sub-Investigator
Chin B Eap, Prof PhD, Sub-Investigator
Karine Lepigeon, Sub-Investigator
Etienne Weisskopf, PharmD, Sub-Investigator
Additional Information

Starting date: April 2014
Last updated: July 27, 2015

Page last updated: August 23, 2015

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