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Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

NCT00525486 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL

Last updated 2010-12-23

No results posted yet for this study

Summary

To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group.

The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.

Conditions

  • Preterm Labor

Interventions

DRUG

Nifedipine extended release

Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation

Sponsors & Collaborators

  • The Baruch Padeh Medical Center, Poriya

    lead OTHER_GOV

Principal Investigators

  • Yuri Perlitz, MD · The Baruch Padeh Medical Center, Poria, Israel.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31

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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 NCT00525486 on ClinicalTrials.gov