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Sponsored by: |
The Baruch Padeh Medical Center, Poriya |
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Information provided by: | The Baruch Padeh Medical Center, Poriya |
ClinicalTrials.gov Identifier: | NCT00525486 |
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.
Condition | Intervention |
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Preterm Labor |
Drug: Nifedipine extended release |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery:A Prospective Interventional Study |
Study Start Date: | December 2007 |
Arms | Assigned Interventions |
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A: Experimental
The treated group of pregnant women, after having successeful treatment for PTL
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Drug: Nifedipine extended release
Nifedipine extended release PO 30 mg X2/d until 34 weeks' gestation
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B: No Intervention
The no treatment arm of women treated with tocolysis for PTL.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | PTL prevention Nifedipine |
Study First Received: | September 2, 2007 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00525486 |
Health Authority: | Israel:IRB Commission (local) |
Nifedipine Tocolysis Maintenance Preterm delivery |
extended release nifedipine maintenance PTL |
Calcium, Dietary Pregnancy Complications Obstetric Labor, Premature |
Obstetric Labor Complications Nifedipine Premature Birth |
Membrane Transport Modulators Vasodilator Agents Tocolytic Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Calcium Channel Blockers Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions |