NCT01314859

Nifedipine Treatment in Preterm Labor

ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital Clinico Universitario de Santiago · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies.

Detailed description

Preterm labor is defined as the presence of uterine contractions of sufficient frequency and intensity to effect progressive effacement and dilation of the cervix prior to term gestation (between 20 and 37 weeks). It is a major health problem of increased incidence, affecting approximately between 7-10% of pregnant women in developed countries with a high socioeconomic costs and high rates of fetal mortality, although perinatal progress. This study may allow to establish the existence of differences in perinatal outcomes and to define the first choice drug for tocolysis.

Conditions

• Threatened Preterm Labor

Interventions

Type	Name	Description
DRUG	Nifedipine	* Oral Treatment with Nifedipine capsules (10mg) * Initial dose: 20 mg of nifedipine (2 capsules of 10 mg). * Maintenance Dose: 20 mg of nifedipine (2 capsules of 10 mg) every 6 hours. * Maximum Duration of the treatment: 48 hours.
DRUG	Atosiban	* Intravenously Treatment with Atosiban (7.5mg/ml) * Initial Dose: IV bolus injection during 1 minute + Intravenous infusion 7.5 mg/ml during 3 hours. * Maintenance: Maintenance intravenous infusion 7.5 mg/ml at least 18 hours to a maximum of 45 hours. * Maximum Duration of the treatment: 48 hours.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-07-01
• Completion: 2013-07-01
• First posted: 2011-03-15
• Last updated: 2014-07-29