Clinical Trial: Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial

Brief Summary:

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.

Detailed Summary:
Sponsor: University Hospital, Rouen

Current Primary Outcome: Prolongation of pregnancy [ Time Frame: From allocation to the delivery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required [ Time Frame: At the end of the study ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: January 28, 2008
Date Started: January 2008
Date Completion:
Last Updated: July 9, 2014
Last Verified: July 2014