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Nifedipine Treatment in Preterm Labor

NCT01314859 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-07-29

No results posted yet for this study

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.

Conditions

  • Threatened Preterm Labor

Interventions

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.

Sponsors & Collaborators

  • Fundación Ramón Domínguez

    collaborator OTHER

  • Hospital Clinico Universitario de Santiago

    lead OTHER

Principal Investigators

  • Manuel Macía Cortiñas, MD · Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain

  • Lourdes González González, MD · Hospital Son Dureta, Mallorca, Spain

  • Javier Martínez Pérez-Mendaña, MD, PhD · Complexo Hospitalario Arquitecto Marcide- Profesor Novoa Santos, Ferrol, Spain

  • José Eloy Moral Santamarina, MD · Complexo Hospitalario de Pontevedra, Pontevedra, Spain

  • Susana Blanco Pérez, MD · Complexo Hospitalario de Ourense; Ourense, Spain

  • Luis Miguel González Seijas, MD · Hospital del Barbanza; Ribeira, A Coruna, Spain

  • Emilio Cabo Silva, MD · Hospital del Salnes; Vilagarcía de Arousa, Pontevedra, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-07-31
Completion
2013-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01314859 on ClinicalTrials.gov