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Sponsored by: |
University Hospital, Rouen |
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Information provided by: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00620724 |
The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.
The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.
Condition | Intervention | Phase |
---|---|---|
Placenta Previa |
Drug: Placebo Drug: Nifedipine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial |
Estimated Enrollment: | 110 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
Placebo three times daily
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Drug: Placebo
Placebo three times daily
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B: Experimental
20 mg of slow-release Nifedipine three times daily
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Drug: Nifedipine
20 mg of slow-release Nifedipine three times daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Verspyck Eric, MD, PhD | 331232888745 | eric.verspyck@chu-rouen.fr |
France | |
University Hospital Rouen | Recruiting |
Rouen, France, 76031 | |
Contact: Verspyck VE Eric, Pr 0232888990 eric.verspyck@chu-rouen.fr |
Responsible Party: | CHU Rouen ( Verspyck Eric, MD, PhD ) |
Study ID Numbers: | 2005/065/HP |
Study First Received: | January 28, 2008 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00620724 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Calcium, Dietary Pregnancy Complications Obstetric Labor Complications Placenta Previa Nifedipine |
Membrane Transport Modulators Placenta Diseases 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 |